HIV InfectionsPhase 3NCT00043966
Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
A Phase 3 study testing Lopinavir/ritonavir, Tenofovir DF and Emtricitabine in people with HIV Infections, run by Abbott at 52 sites in 7 countries.
Trial summary
The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir. 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?
- Lopinavir/ritonavir, Tenofovir DF and Emtricitabine
- How many people
- 200 participants
- Where
- 52 sitesin 7 countries
- Study dates
- Jul 2002to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subject is at least 18 years of age.
- If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: *condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) *contraceptives (oral or parenteral) for three months prior to study drug administration) *a vasectomized partner *total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) and a urine pregnancy test performed on Study Day -1 are both negative and the subject agrees to use a barrier method of contraception throughout the study.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.
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- Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
- Subject agrees not to take any medication during the study, including over-the-counter medicine, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
- Subject has a Karnofsky Score greater than or equal to 70
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.
- Subject is naive to antiretroviral treatment (< 7 days ARV treatment).
- Subject has a plasma HIV RNA level of greater than 1,000 copies/mL at screening.
- Subject agrees to take all doses of the lopinavir/ritonavir from the bottles provided by the sponsor (rather than take doses from a personal "dosette" box).
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Who cannot join
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.
- Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
- Subject has a positive result on the screening tests for drugs of abuse.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
- Screening laboratory analyses show any of the following abnormal laboratory results: *Hemoglobin ≤ 8.0 g/dL *Absolute neutrophil count ≤ 750 cells/µL *Platelet count ≤ 50,000 per mL *ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN) *Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
- Subject has received any investigational drug within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
Trial locations and contacts
52 sites in 7 countries.
52 sites in 7 countries
United States29 sites
Akron Infectious Disease, Inc.
Akron, Ohio, 44304
IDS Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta Inc.
Atlanta, Georgia, 30308
South Florida Clinical Research
Atlantis, Florida, 33462
Central Texas Clinical Research
Austin, Texas, 78705
Pacific Oaks Research
Beverly Hills, California, 90211
Comprehensive Care Center
Fort Lauderdale, Florida, 33311
Gary J. Richmond, MD
Fort Lauderdale, Florida, 33316
Associates in Research
Fort Myers, Florida, 33901
Orange County Center for Special Immunology
Fountain Valley, California, 92708
Hampton Roads Medical Specialists
Hampton, Virginia, 23666
Joseph C. Gathe, Jr, MD
Houston, Texas, 77004
Southampton Medical Group
Houston, Texas, 77098
Living Hope Clinical Foundation
Long Beach, California, 90813
AIDS Healthcare Foundation Research Center
Los Angeles, California, 90027
Drs. Combs and Lutz
New Orleans, Louisiana, 70115
Polari Medical Group
New York, New York, 10011
St. Michael's Medical Center
Newark, New Jersey, 07102-9880
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Triangle Medical
Philadelphia, Pennsylvania, 19107
Phoenix Body Positive
Phoenix, Arizona, 85006
Morris, Sklaver, Mestre & Denney, M.D., PA
Plantation, Florida, 33317
The Research & Education Group
Portland, Oregon, 97209-2535
Health Positive
Safety Harbor, Florida, 34695
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614
Associates in Medical and Mental Health, P.C.
Tulsa, Oklahoma, 74114
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Donna E. Sweet, MD
Wichita, Kansas, 67214
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1042
Spain7 sites
Hospital Germans Trias I Pujol
Badalona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Vall D'Hebron
Barcelona, 08035
L'Hospitalet de Llobregat
Barcelona, 08907
Hospital 12 de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital de Mostolesi
Madrid, 28935
France6 sites
CHU Kremlin Bicetre
Le Kremlin-Bicêtre, 94272
Hopital l'Archet
Nice, 06202
Hopital Saint Louis
Paris, Cedex 10, 75475
Hopital Saint Antoine
Paris, Cedex 12, 75571
Hopital Tenon
Paris, Cedex 20, 75970
Hopital Bichat
Paris, 75018
United Kingdom5 sites
Brighton General Hospital
E. Sussex, BN2 3EW
Royal Free Hospital
London, NW3 2QG
The Caldecot Centre King's Healthcare NHS Trust
London, SE5 9RS
St. Stephen's Centre Chelsea & Westminster Hospital
London, SW10 9TH
St. Mary Hospital
London, W2 1NY
Australia2 sites
Ground Zero Medical Centre / AIDS Research Initiative
Darlinghurst, New South Wales, 2010
Holdsworth House General Practice
Darlinghurst, New South Wales, 2010
Germany2 sites
Klinik I fur Innere Medizin der Universitat zu Koln
Cologne, D-505924
Klinikum J.W. Goethe Universitat
Frankfurt, D-60590
About this study
Official title: A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir, Tenofovir DF, Emtricitabine
- Keywords
- treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavirDrug
Tenofovir DFDrug
EmtricitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2002 (estimated)
- Study startJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 200 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Brun, M.D., Study director, Global Project Head, Antiviral Global Project Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043966
- Sponsor's protocol ID
- M02-418
- Status last verified
- Jul 2006
- First submitted
- 15 Aug 2002
- Last updated
- 27 Jul 2006
- Results posted
- No
Publications
Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.
PubMed 18190257
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
- ClinicalTrials.gov ID
- NCT00043966
- Acronym / sponsor ID
- M02-418
- Conditions
- HIV Infections
- Keywords
- treatment naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- First posted
- 19 Aug 2002 (estimated)
- Results
- Not posted in the source record
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 between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is at least 18 years of age.
- If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: *condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) *contraceptives (oral or parenteral) for three months prior to study drug administration) *a vasectomized partner *total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) and a urine pregnancy test performed on Study Day -1 are both negative and the subject agrees to use a barrier method of contraception throughout the study.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
Key exclusion criteria (7 listed)
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.
- Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
- Subject has a positive result on the screening tests for drugs of abuse.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
- Screening laboratory analyses show any of the following abnormal laboratory results: *Hemoglobin ≤ 8.0 g/dL *Absolute neutrophil count ≤ 750 cells/µL *Platelet count ≤ 50,000 per mL *ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN) *Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
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 | Drug | – |
| Tenofovir DF | Drug | – |
| Emtricitabine | Drug | – |
Primary outcome
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2006.
- Derived from this study: PubMed 18190257Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.
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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.
Scott Brun, M.D. study director
Global Project Head, Antiviral Global Project Team
52 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, Tenofovir DF and Emtricitabine in people with HIV Infections, run by Abbott at 52 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 14 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 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Spain, France, United Kingdom, Australia 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48. 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 NCT00043966, which also lists 1 linked publication.
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 Jul 2006.