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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

NCT01620944 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-01-10

Study results available
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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

Interventions

DRUG

Atazanavir

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

DRUG

Ritonavir

Tablets, oral, 100 mg, QD, 96 Weeks

DRUG

Lamivudine

Tablet, oral, 300 mg, QD, 96 Weeks

DRUG

Tenofovir/Emtricitabine

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-01-22
Completion
2013-01-22

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620944 on ClinicalTrials.gov