HIV InfectionsPhase 4NCT00552240
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
A Phase 4 study testing tenofovir DF 300 mg QD, emtricitabine 200 mg QD and Nevirapine 200 mg BID in people with HIV Infections, run by Boehringer Ingelheim at 19 sites in United States.
Trial summary
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- tenofovir DF 300 mg QD, emtricitabine 200 mg QD and Nevirapine 200 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2007to Mar 2010
- Phase
- Phase 4
- 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
- Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
- HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot
- No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
- No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
- Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
- NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
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- Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
- Karnofsky score greater than or equal to 70 (see Appendix 10.7)
- Acceptable medical history, as assessed by the investigator
Who cannot join
- History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
- Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
- Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives
- Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
- Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1)
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- Known hypersensitivity to any ingredients in nevirapine or atazanavir
- Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
- Use of other investigational medications within 30 days before study entry or during the trial
- Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
- Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma
- Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit
- Patients who are receiving systemic chemotherapy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
1100.1512.27 Boehringer Ingelheim Investigational Site
Annandale, Virginia
1100.1512.28 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1512.13 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1100.1512.30 Boehringer Ingelheim Investigational Site
Dallas, Texas
1100.1512.15 Boehringer Ingelheim Investigational Site
Denver, Colorado
1100.1512.17 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1100.1512.19 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1100.1512.16 Boehringer Ingelheim Investigational Site
Houston, Texas
1100.1512.24 Boehringer Ingelheim Investigational Site
Houston, Texas
1100.1512.20 Boehringer Ingelheim Investigational Site
Los Angeles, California
1100.1512.29 Boehringer Ingelheim Investigational Site
Maywood, Illinois
1100.1512.11 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey
1100.1512.25 Boehringer Ingelheim Investigational Site
Newark, New Jersey
1100.1512.14 Boehringer Ingelheim Investigational Site
Orlando, Florida
1100.1512.21 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1100.1512.18 Boehringer Ingelheim Investigational Site
Somers Point, New Jersey
1100.1512.23 Boehringer Ingelheim Investigational Site
Vero Beach, Florida
1100.1512.26 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1100.1512.22 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
About this study
Official title: Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).
- Conditions
- HIV Infections
- Being tested
- tenofovir DF 300 mg QD, emtricitabine 200 mg QD, Nevirapine 200 mg BID, Atazanavir 300 mg, Ritonavir 100 mg
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir DF 300 mg QDDrug
300 mg QD
tenofovir DF 300 mg QDDrug
300 mg QD
emtricitabine 200 mg QDDrug
200 mg QD
emtricitabine 200 mg QDDrug
200 mg QD
Nevirapine 200 mg BIDDrug
200 mg BID
Atazanavir 300 mgDrug
300 mg QD
Ritonavir 100 mgDrug
100 mg QD
| Study group | Role | What they receive |
|---|---|---|
| NVP 200mg bis indie (BID) | Active comparator | after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks Receives: Drug: tenofovir DF 300 mg QD; Drug: emtricitabine 200 mg QD; Drug: Nevirapine 200 mg BID |
| Atazanavir 300 mg QD/ritonavir 100 mg QD | Active comparator | patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks Receives: Drug: tenofovir DF 300 mg QD; Drug: emtricitabine 200 mg QD; Drug: Atazanavir 300 mg; Drug: Ritonavir 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Virologic Response (VR)
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Measured: baseline to week 48
Secondary outcomes (47)
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
Measured: baseline to week 48
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Measured: baseline to week 48
Number of Participants With Virologic Success (FDA Definition)
HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Measured: baseline to week 48
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time to response whereby patients withdrawing early were censored after their withdrawal
Measured: baseline to week 48
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Measured: baseline to week 48
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Measured: baseline to week 24 and week 48
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 2
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 4
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 6
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 8
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 12
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 24
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 36
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 48
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 2
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 4
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 6
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 8
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 12
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 24
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 36
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Measured: baseline to week 48
Number of Patients With Virologic Rebound to >400 Copies/ml
HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Measured: baseline to week 48
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.
Number of cases (no time-to analysis was performed due to small numbers).
Measured: baseline to week 48
Change in CD4+ Cell Count From Baseline to Week 2.
Patients on-treatment, data within time windows
Measured: baseline to week 2
Change in CD4+ Cell Count From Baseline to Week 4.
Patients on-treatment, data within time windows
Measured: baseline to week 4
Change in CD4+ Cell Count From Baseline to Week 6.
Patients on-treatment, data within time windows
Measured: baseline to week 6
Change in CD4+ Cell Count From Baseline to Week 8.
Patients on-treatment, data within time windows
Measured: baseline to week 8
Change in CD4+ Cell Count From Baseline to Week 12.
Patients on-treatment, data within time windows
Measured: baseline to week 12
Change in CD4+ Cell Count From Baseline to Week 24.
Patients on-treatment, data within time windows
Measured: baseline to week 24
Change in CD4+ Cell Count From Baseline to Week 36.
Patients on-treatment, data within time windows
Measured: baseline to week 36
Change in CD4+ Cell Count From Baseline to Week 48.
Patients on-treatment, data within time windows
Measured: baseline to week 48
Change in Fasting Plasma Total Cholesterol Level
Measured: baseline to week 48
Change in Fasting Plasma Triglycerides Level
Measured: baseline to week 48
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Measured: baseline to week 48
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Measured: baseline to week 48
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Measured: baseline to week 48
Change in Framingham Score
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Measured: baseline to week 48
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Measured: baseline to week 48
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Measured: baseline to week 48
Percentage Adherence by Pill Count
Number of pills not returned / number of treatment days in percent (%)
Measured: baseline to week 48
Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Measured: baseline to week 48
Incidence of Patients With AIDS Progression at Each Visit
Cumulative incidence of patients with AIDS progression are shown
Measured: baseline to week 52
Proportion of Patients Reporting CNS Side Effects of Any Severity
Measured: baseline to week 52
Proportion of Patients Reporting Hepatic Events of Any Severity
Measured: baseline to week 52
Proportion of Patients Reporting Rash of Any Severity
Measured: baseline to week 52
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Measured: baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionMar 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.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552240
- Sponsor's protocol ID
- 1100.1512
- Status last verified
- Dec 2013
- First submitted
- 28 Sep 2007
- Last updated
- 27 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
- ClinicalTrials.gov ID
- NCT00552240
- Acronym / sponsor ID
- 1100.1512
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 23 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVP 200mg bis indie (BID) | Active comparator | Drug: tenofovir DF 300 mg QD, Drug: emtricitabine 200 mg QD, Drug: Nevirapine 200 mg BIDafter receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks |
| Atazanavir 300 mg QD/ritonavir 100 mg QD | Active comparator | Drug: tenofovir DF 300 mg QD, Drug: emtricitabine 200 mg QD, Drug: Atazanavir 300 mg, Drug: Ritonavir 100 mgpatients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
- HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot
- No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
- No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
- Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
Key exclusion criteria (13 listed)
- History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
- Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
- Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives
- Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
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 |
|---|---|---|
| tenofovir DF 300 mg QD300 mg QD | Drug | Atazanavir 300 mg QD/ritonavir 100 mg QD |
| tenofovir DF 300 mg QD300 mg QD | Drug | NVP 200mg bis indie (BID) |
| emtricitabine 200 mg QD200 mg QD | Drug | Atazanavir 300 mg QD/ritonavir 100 mg QD |
| emtricitabine 200 mg QD200 mg QD | Drug | NVP 200mg bis indie (BID) |
| Nevirapine 200 mg BID200 mg BID | Drug | NVP 200mg bis indie (BID) |
| Atazanavir 300 mg300 mg QD | Drug | Atazanavir 300 mg QD/ritonavir 100 mg QD |
| Ritonavir 100 mg100 mg QD | Drug | Atazanavir 300 mg QD/ritonavir 100 mg QD |
Primary outcome
Number of Participants With Virologic Response (VR)
Time frame: baseline to week 48
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
47 secondary outcomes
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Time frame: baseline to week 48
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Time frame: baseline to week 48
Number of Participants With Virologic Success (FDA Definition)
Time frame: baseline to week 48
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time frame: baseline to week 48
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Time frame: baseline to week 48
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
Time frame: baseline to week 24 and week 48
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Time frame: baseline to week 2
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Time frame: baseline to week 4
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Time frame: baseline to week 6
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Time frame: baseline to week 8
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Time frame: baseline to week 12
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Time frame: baseline to week 24
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Time frame: baseline to week 36
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Time frame: baseline to week 48
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Time frame: baseline to week 2
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Time frame: baseline to week 4
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Time frame: baseline to week 6
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Time frame: baseline to week 8
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Time frame: baseline to week 12
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Time frame: baseline to week 24
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Time frame: baseline to week 36
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Time frame: baseline to week 48
Number of Patients With Virologic Rebound to >400 Copies/ml
Time frame: baseline to week 48
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
Time frame: baseline to week 48
Change in CD4+ Cell Count From Baseline to Week 2.
Time frame: baseline to week 2
Change in CD4+ Cell Count From Baseline to Week 4.
Time frame: baseline to week 4
Change in CD4+ Cell Count From Baseline to Week 6.
Time frame: baseline to week 6
Change in CD4+ Cell Count From Baseline to Week 8.
Time frame: baseline to week 8
Change in CD4+ Cell Count From Baseline to Week 12.
Time frame: baseline to week 12
Change in CD4+ Cell Count From Baseline to Week 24.
Time frame: baseline to week 24
Change in CD4+ Cell Count From Baseline to Week 36.
Time frame: baseline to week 36
Change in CD4+ Cell Count From Baseline to Week 48.
Time frame: baseline to week 48
Change in Fasting Plasma Total Cholesterol Level
Time frame: baseline to week 48
Change in Fasting Plasma Triglycerides Level
Time frame: baseline to week 48
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Time frame: baseline to week 48
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Time frame: baseline to week 48
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Time frame: baseline to week 48
Change in Framingham Score
Time frame: baseline to week 48
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Time frame: baseline to week 48
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
Time frame: baseline to week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tenofovir DF 300 mg QD, emtricitabine 200 mg QD and Nevirapine 200 mg BID in people with HIV Infections, run by Boehringer Ingelheim at 19 sites in United States.
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 9 inclusion and 13 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 May 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?
Number of Participants With Virologic Response (VR) (time frame: baseline to week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2014.