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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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 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

NCT01620944•Bristol-Myers Squibb

View on ClinicalTrials.gov

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 \[Lamivudine (3TC) 300 mg daily\] or 2 additional drugs \[Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily\].

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- Signed Written Informed Consent.
•i) 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.
•ii) 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.
•i) Treatment-naive HIV-1-infected subjects (\< 48 hours of any ARV is allowed).
•ii) Subjects who have an HIV-1 Ribonucleic acid (RNA) level ≥ 1000 c/mL at screening.
•iii) Subjects who have a Antigenic marker of helper/inducer T lymphocytes (CD4) + cell count \> 100 cells/mm3.
•\- Age and Reproductive Status.
•i) Men and women, 18 years of age or older (or minimum age as determined by local regulatory or legal requirements).
•ii) 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.
+8 more criteria

Exclusion Criteria

•\- Target Disease Exceptions.
•i) Subjects who have an HIV-1 RNA level ≥500,000 c/mL at screening.
•ii) Screening HIV genotype showing resistance to any component of the study regimen (ATV, RTV, 3TC, TDF/FTC).
•iii) Previously documented HIV-2 infection.
•\- Medical History and Concurrent Diseases.
•i) Acute or chronic hepatitis B virus (HBV) or Acute hepatitis C virus (HCV) co-infection.
•i) 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.
•ii) Primary HIV infection.
•iii) 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:.
•A. PR Interval \> 260 msec (severe 1st degree AV Block).
+22 more criteria

Key Dates

Start Date

July 31, 2012

Primary Completion Date

January 22, 2013

Completion Date

January 22, 2013

Last Updated

January 10, 2024

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

Atazanavir

DRUG

Ritonavir

DRUG

Lamivudine

DRUG

Tenofovir/Emtricitabine

DRUG

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE2

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NCT04929028

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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