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

NCT01620944 | Terminated Phase 3 Results

• 2 other identifiers: AI424-4942011-006187-47
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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 \[Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily\].

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 48

Secondary Outcomes (5)

• Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48

  Week 48

• Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96

  Week 96

• Incidence of Adverse Events Through Weeks 48 and 96

  through weeks 48 and 96

• Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96

  Weeks 48 and 96

• Incidence of Newly Emergent Genotypic Substitutions and Phenotypic Resistance to Study Drugs for Virologic Failures Through Week 48 and 96

  Through week 48 and 96

Study Arms (2)

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

Interventions

Atazanavir DRUG

Capsule, oral, 300 mg, Once daily (QD), 96 weeks

Arm1: ATV/RTVHS+3TC; Arm2: ATV/RTVHS+TDF/FTC

Ritonavir DRUG

Tablets, oral, 100 mg, QD, 96 Weeks

Also known as: Ritonavir high sensitivity (RTV HS)

Arm1: ATV/RTVHS+3TC; Arm2: ATV/RTVHS+TDF/FTC

Lamivudine DRUG

Tablet, oral, 300 mg, QD, 96 Weeks

Arm1: ATV/RTVHS+3TC

Tenofovir/Emtricitabine DRUG

Tablets, oral, 300/200 mg, QD, 48 Weeks

Arm2: ATV/RTVHS+TDF/FTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• iii) Acceptable methods of highly effective birth control include:.
• A. Condom with spermicide.
• B. Diaphragm and spermicide.
• C. 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).

You may not qualify if:

• \- 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.
• A. PR Interval \> 260 msec (severe 1st degree AV Block).
• B. QRS Interval \> 120 msec.
• iv) Moderate-to-severe hepatic insufficiency.
• v) Obstructive liver disease.
• vi) 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.
• vii) Concomitant administration of a proton pump inhibitor (PPI) or H2 blocker or any other drug with potential interaction with the investigational products.
• viii) Life expectancy \< 1 year according to the judgment of the investigator.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Interventions

Atazanavir Sulfate; Ritonavir; Lamivudine; Tenofovir; Emtricitabine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: July 31, 2012
• Primary Completion: January 22, 2013
• Study Completion: January 22, 2013
• Last Updated: January 10, 2024
• Results First Posted: August 6, 2021

Record last verified: 2024-01