HIVPhase 3NCT01620944
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
A Phase 3 study testing Atazanavir, Ritonavir and Lamivudine in people with HIV, run by Bristol-Myers Squibb.
Trial summary
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug [Lamivudine (3TC) 300 mg… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Atazanavir, Ritonavir and Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2012to 22 Jan 2013
- 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
- Signed Written Informed Consent.
- Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial.
- A freely given Pharmacokinetics (PK) sub-study consent form must be obtained from the subset of subjects participating in the intensive PK sub-study.
- Target Population.
- Treatment-naive HIV-1-infected subjects (< 48 hours of any ARV is allowed).
- Subjects who have an HIV-1 Ribonucleic acid (RNA) level ≥ 1000 c/mL at screening.
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- Subjects who have a Antigenic marker of helper/inducer T lymphocytes (CD4) + cell count > 100 cells/mm3.
- Age and Reproductive Status.
- Men and women, 18 years of age or older (or minimum age as determined by local regulatory or legal requirements).
- Women of childbearing potential (WOCBP) must use highly effective methods of birth control for up to 8 weeks after the last dose of investigational product to minimize the risk of pregnancy. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of 30 days after dosing has been completed.
- Acceptable methods of highly effective birth control include:.
- Condom with spermicide.
- Diaphragm and spermicide.
- Cervical cap and spermicide
- Since acceptable and available methods of contraception vary among different countries, participating women may choose their preferred contraceptive method atazanavir AI424494 BMS-232632 Clinical Protocol Date: 31-01-2012 33 based on physician recommendations. Caution is warranted with co-administration of oral contraceptives (ethinyl estradiol and norethindrone).
- Women must have a negative serum or urine pregnancy test [minimum sensitivity 25 IU/L or equivalent units of Human chorionic gonadotropin (HCG)] within 24 hours prior to the start of investigational product.
- Women must not be breastfeeding.
- Sexually active fertile men must use highly effective birth control if their partners are WOCBP.
Who cannot join
- Target Disease Exceptions.
- Subjects who have an HIV-1 RNA level ≥500,000 c/mL at screening.
- Screening HIV genotype showing resistance to any component of the study regimen (ATV, RTV, 3TC, TDF/FTC).
- Previously documented HIV-2 infection.
- Medical History and Concurrent Diseases.
- Acute or chronic hepatitis B virus (HBV) or Acute hepatitis C virus (HCV) co-infection.
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- Note Chronic co-infection with hepatitis C is not exclusion criteria. Subjects with acute hepatitis C may have the option to be screened after the event has evolved into a chronic infection.
- Presence of a newly diagnosed HIV-related opportunistic infection (OI) or any medical condition requiring acute therapy at the time of enrollment. Subjects on stable maintenance therapy for an OI may be enrolled.
- Primary HIV infection.
- History or current cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including left bundle branch block (LBB) or left anterior fascicular block (LAFB), 2nd or 3rd-degree atrioventricular block (AVB), or any cardiac abnormality deemed clinically significant by the investigator. In addition, the following Electrocardiogram (ECG) findings are exclusionary:.
- PR Interval > 260 msec (severe 1st degree AV Block).
- QRS Interval > 120 msec.
- Moderate-to-severe hepatic insufficiency.
- Obstructive liver disease.
- Recent therapy with agents having significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment, or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4.
- Concomitant administration of a proton pump inhibitor (PPI) or H2 blocker or any other drug with potential interaction with the investigational products.
- Life expectancy < 1 year according to the judgment of the investigator.
- Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
- History or ongoing psychiatry disorder.
- Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.
- Physical and Laboratory Test Findings.
- Screening laboratory analysis shows any of the following abnormal laboratory results:.
- Grade IV glucose.
- Grade IV electrolytes.
- Grade IV transaminases.
- Grade IV hematology.
- Calculated creatinine clearance < 60 mL/min as estimated by the Cockcroft-Gault equation.
- Allergies and Adverse Drug Reaction.
- Hypersensitivity to any component of the study drug formulations.
- Sex and Reproductive Status.
- Pregnancy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
About this study
Official title: A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].
- Conditions
- HIV
- Being tested
- Atazanavir, Ritonavir, Lamivudine, Tenofovir/Emtricitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Capsule, oral, 300 mg, Once daily (QD), 96 weeks
RitonavirDrug
Also called Ritonavir high sensitivity (RTV HS)
Tablets, oral, 100 mg, QD, 96 Weeks
LamivudineDrug
Tablet, oral, 300 mg, QD, 96 Weeks
Tenofovir/EmtricitabineDrug
Tablets, oral, 300/200 mg, QD, 48 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm1: ATV/RTVHS+3TC | Experimental | Not described Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Lamivudine |
| Arm2: ATV/RTVHS+TDF/FTC | Active comparator | Not described Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir/Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
Proportion of subjects with HIV-1 RNA < 40 c/mL at Week 48.
Measured: Week 48
Secondary outcomes (5)
Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48
Proportion of Participants with HIV-1 RNA < 400 c/mL at Week 48.
Measured: Week 48
Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96
proportion of subjects with HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96.
Measured: Week 96
Incidence of Adverse Events Through Weeks 48 and 96
Incidence of Adverse Events through weeks 48 and 96 including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation.
There were no SAEs or AEs reported in this early terminated study.
Measured: through weeks 48 and 96
Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96
Percent change from baseline in eGFR and bone mineral density at weeks 48 and 96.
Measured: Weeks 48 and 96
Incidence of Newly Emergent Genotypic Substitutions and Phenotypic Resistance to Study Drugs for Virologic Failures Through Week 48 and 96
Incidence of newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failures through Week 48 and 96.
Measured: Through week 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start31 Jul 2012
- Primary completion22 Jan 2013
- Study completion22 Jan 2013
Why it stopped: Business objectives have changed
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 HIVStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620944
- Sponsor's protocol ID
- AI424-494
- Other IDs
- 2011-006187-47
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2012
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC
- ClinicalTrials.gov ID
- NCT01620944
- Acronym / sponsor ID
- AI424-494
- Conditions
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2012 (actual)
- Primary completion
- 22 Jan 2013 (actual)
- Study completion
- 22 Jan 2013 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: ATV/RTVHS+3TC | Experimental | Drug: Atazanavir, Drug: Ritonavir, Drug: Lamivudine |
| Arm2: ATV/RTVHS+TDF/FTC | Active comparator | Drug: Atazanavir, Drug: Ritonavir, Drug: Tenofovir/Emtricitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed Written Informed Consent.
- Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial.
- A freely given Pharmacokinetics (PK) sub-study consent form must be obtained from the subset of subjects participating in the intensive PK sub-study.
- Target Population.
- Treatment-naive HIV-1-infected subjects (< 48 hours of any ARV is allowed).
Key exclusion criteria (34 listed)
- Target Disease Exceptions.
- Subjects who have an HIV-1 RNA level ≥500,000 c/mL at screening.
- Screening HIV genotype showing resistance to any component of the study regimen (ATV, RTV, 3TC, TDF/FTC).
- Previously documented HIV-2 infection.
- Medical History and Concurrent Diseases.
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 |
|---|---|---|
| AtazanavirCapsule, oral, 300 mg, Once daily (QD), 96 weeks | Drug | Arm1: ATV/RTVHS+3TC, Arm2: ATV/RTVHS+TDF/FTC |
| RitonavirAlso: Ritonavir high sensitivity (RTV HS)Tablets, oral, 100 mg, QD, 96 Weeks | Drug | Arm1: ATV/RTVHS+3TC, Arm2: ATV/RTVHS+TDF/FTC |
| LamivudineTablet, oral, 300 mg, QD, 96 Weeks | Drug | Arm1: ATV/RTVHS+3TC |
| Tenofovir/EmtricitabineTablets, oral, 300/200 mg, QD, 48 Weeks | Drug | Arm2: ATV/RTVHS+TDF/FTC |
Primary outcome
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
Time frame: Week 48
Proportion of subjects with HIV-1 RNA < 40 c/mL at Week 48.
5 secondary outcomes
Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48
Time frame: Week 48
Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96
Time frame: Week 96
Incidence of Adverse Events Through Weeks 48 and 96
Time frame: through weeks 48 and 96
Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96
Time frame: Weeks 48 and 96
Incidence of Newly Emergent Genotypic Substitutions and Phenotypic Resistance to Study Drugs for Virologic Failures Through Week 48 and 96
Time frame: Through week 48 and 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir, Ritonavir and Lamivudine in people with HIV, run by Bristol-Myers Squibb.
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 18 inclusion and 34 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: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 6 Aug 2021). 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?
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48 (time frame: 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 10 Jan 2024.