Human Immunodeficiency Virus InfectionPhase 3PROGRESSNCT00711009
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
A Phase 3 study testing lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and raltegravir (RAL) in people with Human Immunodeficiency Virus Infection, run by Abbott at 37 sites in 7 countries.
Trial summary
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- What is being tested?
- lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and raltegravir (RAL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 37 sitesin 7 countries
- Study dates
- Jul 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must provide written, voluntary informed consent to participate in the study.
- Participants must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.
- Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.
- Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.
- Participant does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Participant agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the principal investigator.
- Female participants must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the participant and investigator. All female participants must have a urine pregnancy test performed at screening visit and on Day minus 1/baseline, and results of both tests must be negative. Female participants may not be breastfeeding.
- Participants have received no prior treatment with an HIV-1 integrase inhibitor.
Who cannot join
- Participants must not have history of an allergic reaction or significant sensitivity to the study drugs.
- Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
- Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
- Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
- Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
- Participants may not have any of the following abnormal screening results: Hemoglobin <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Platelet count <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinine clearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.
- The investigator considers the participant to be an unsuitable candidate for the study.
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States14 sites
Site Reference ID/Investigator# 8395
Atlanta, Georgia, 30303
Site Reference ID/Investigator# 8394
Atlantis, Florida, 33462
Site Reference ID/Investigator# 8432
Beverly Hills, California, 90211
Site Reference ID/Investigator# 8424
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 8426
Charlotte, North Carolina, 28209
Site Reference ID/Investigator# 8403
Dallas, Texas, 75246
Site Reference ID/Investigator# 8429
Decatur, Georgia, 30033
Site Reference ID/Investigator# 8393
Ft. Pierce, Florida, 34982
Site Reference ID/Investigator# 8433
Houston, Texas, 77004
Site Reference ID/Investigator# 11461
Huntersville, North Carolina, 28078
Site Reference ID/Investigator# 8425
Orlando, Florida, 32803
Site Reference ID/Investigator# 8431
Phoenix, Arizona, 85006
Site Reference ID/Investigator# 8402
Tampa, Florida, 33614
Site Reference ID/Investigator# 8396
Vero Beach, Florida, 32960
Spain8 sites
Site Reference ID/Investigator# 11102
Barcelona, 08041
Site Reference ID/Investigator# 7697
Barcelona, 08916
Site Reference ID/Investigator# 7689
Barcelona, 8036
Site Reference ID/Investigator# 7692
L'Hospitalet de Llobregat, 08907
Site Reference ID/Investigator# 7698
Madrid, 28006
Site Reference ID/Investigator# 7693
Madrid, 28041
Site Reference ID/Investigator# 7691
Madrid, 28046
Site Reference ID/Investigator# 7690
Seville, 41013
Canada4 sites
Site Reference ID/Investigator# 8099
Montreal, Quebec, H2L 5B1
Site Reference ID/Investigator# 7963
Ottawa, Ontario, K1H 8L6
Site Reference ID/Investigator# 7831
Toronto, Ontario, M4N 3M5
Site Reference ID/Investigator# 7959
Toronto, Ontario, M5B 1L6
France4 sites
Site Reference ID/Investigator# 7695
Lyon, 69317
Site Reference ID/Investigator# 7960
Montpellier, 34295
Site Reference ID/Investigator# 8063
Paris, 75012
Site Reference ID/Investigator# 7821
Paris, 75014
Italy4 sites
Site Reference ID/Investigator# 8052
Genoa, 16132
Site Reference ID/Investigator# 7789
Milan, 20127
Site Reference ID/Investigator# 8051
Perugia, 06156
Site Reference ID/Investigator# 8050
Rome, 00184
Puerto Rico2 sites
Site Reference ID/Investigator# 7713
Bayamón, 00959
Site Reference ID/Investigator# 7700
Ponce, 00717-1563
About this study
Official title: A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), raltegravir (RAL)
- Keywords
- Human Immunodeficiency Virus infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavir (LPV/r)Drug
Also called ABT-378, lopinavir/ritonavir, LPV/r, Kaletra
LPV/r 400/100 mg BID
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)Drug
Also called emtricitabine/tenofovir disoproxil fumarate, FTC/TDF, Truvada
FTC/TDF 200/300 mg QD
raltegravir (RAL)Drug
Also called raltegravir, RAL, Isentress, MK-0518
RAL 400 mg BID
| Study group | Role | What they receive |
|---|---|---|
| LPV/r + FTC/TDF | Active comparator | lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily Receives: Drug: lopinavir/ritonavir (LPV/r); Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) |
| LPV/r + RAL | Experimental | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily Receives: Drug: lopinavir/ritonavir (LPV/r); Drug: raltegravir (RAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Measured: Baseline to Week 48
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.
Measured: Week 96
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.
Measured: Baseline to Week 96
Secondary outcomes (79)
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Measured: Baseline to Week 96
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Measured: Baseline to Week 96
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.
Measured: Baseline to Week 96
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.
Measured: Baseline to Week 96
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.
Measured: Baseline to Week 96
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.
Measured: Baseline to Week 96
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.
Measured: Baseline to Week 96
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.
Measured: Week 96
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.
Measured: Week 96
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.
Measured: Week 96
Mean Change From Baseline in Hemoglobin (Grams/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Hematocrit (Fraction)
Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.
Measured: Baseline to Week 96
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Monocytes (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Basophils (x 10^9/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Creatinine (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Calcium (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Sodium (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Potassium (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Chloride (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Albumin (Grams/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Total Protein (Grams/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Measured: Baseline to Week 96
Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
Measured: Baseline to Week 96
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Lipase (Units/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Magnesium (Millimoles/Liter)
Measured: Baseline to Week 96
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Lactate (Millimoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Insulin (Picomoles/Liter)
Included in measures of metabolic toxicity
Measured: Baseline to Week 96
Mean Change From Baseline in Urine Specific Gravity
Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.
Measured: Baseline to Week 96
Mean Change From Baseline in Urine pH
Measured: Baseline to Week 96
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
Measured: Baseline to Week 96
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
Measured: Baseline to Week 96
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
Measured: Baseline to Week 96
Mean Change From Baseline in Weight (kg)
Measured: Baseline to Week 96
Mean Change From Baseline in Temperature (°F)
Measured: Baseline to Week 96
Mean Change From Baseline in Chest Measurement (cm)
Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.
Measured: Baseline to Week 96
Mean Change From Baseline in Waist Measurement (cm)
Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.
Measured: Baseline to Week 96
Mean Change From Baseline in Mid-Arm Measurement (cm)
Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.
Measured: Baseline to Week 96
Mean Change From Baseline in Hips Measurement (cm)
Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.
Measured: Baseline to Week 96
Mean Change From Baseline in Mid-Thigh Measurement (cm)
Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Measured: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Measured: Baseline to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Thomas J Podsadecki, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711009
- Sponsor's protocol ID
- M10-336
- Other IDs
- 2008-000881-22, 2008
- Acronym
- PROGRESS
- Status last verified
- Feb 2012
- First submitted
- 3 Jul 2008
- Last updated
- 14 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3.
PubMed 22730929Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
PubMed 22180523
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00711009
- Acronym / sponsor ID
- PROGRESS / M10-336
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Human Immunodeficiency Virus infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 2 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPV/r + FTC/TDF | Active comparator | Drug: lopinavir/ritonavir (LPV/r), Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily |
| LPV/r + RAL | Experimental | Drug: lopinavir/ritonavir (LPV/r), Drug: raltegravir (RAL)lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must provide written, voluntary informed consent to participate in the study.
- Participants must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.
- Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.
- Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.
- Participant does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Participant agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the principal investigator.
Key exclusion criteria (7 listed)
- Participants must not have history of an allergic reaction or significant sensitivity to the study drugs.
- Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
- Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
- Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
- Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lopinavir/ritonavir (LPV/r)Also: ABT-378, lopinavir/ritonavir, LPV/r, KaletraLPV/r 400/100 mg BID | Drug | LPV/r + FTC/TDF, LPV/r + RAL |
| emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)Also: emtricitabine/tenofovir disoproxil fumarate, FTC/TDF, TruvadaFTC/TDF 200/300 mg QD | Drug | LPV/r + FTC/TDF |
| raltegravir (RAL)Also: raltegravir, RAL, Isentress, MK-0518RAL 400 mg BID | Drug | LPV/r + RAL |
Primary outcome
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
Time frame: Baseline to Week 48
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Time frame: Week 96
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Time frame: Baseline to Week 96
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.
79 secondary outcomes
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
Time frame: Baseline to Week 96
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Time frame: Baseline to Week 96
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Time frame: Baseline to Week 96
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Time frame: Baseline to Week 96
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Time frame: Baseline to Week 96
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
Time frame: Baseline to Week 96
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
Time frame: Baseline to Week 96
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Week 96
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
Time frame: Week 96
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
Time frame: Week 96
Mean Change From Baseline in Hemoglobin (Grams/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Hematocrit (Fraction)
Time frame: Baseline to Week 96
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Monocytes (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Basophils (x 10^9/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Creatinine (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Calcium (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Sodium (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Potassium (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Chloride (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Albumin (Grams/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Total Protein (Grams/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Time frame: Baseline to Week 96
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Time frame: Baseline to Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22730929Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3.
- Derived from this study: PubMed 22180523Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Podsadecki, MD study director
Abbott
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and raltegravir (RAL) in people with Human Immunodeficiency Virus Infection, run by Abbott at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Spain, Canada, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm (time frame: Baseline to Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711009, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.