Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments 150 mg tablet gs- 9350, ritonavir 100 mg capsule, atazanavir 300 mg capsule, emtricitabine/tenofovir df 200/300 mg tablet, ritonavir placebo, gs-9350 placebo
Phase phase 2
Sponsor Gilead Sciences
Start date June 2009
End date December 2009
Trial size 85 participants
Trial identifier NCT00892437, GS-US-216-0105

Summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing GS-9350-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naive adult subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
GS-9350 150 mg QD + ritonavir placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 50)
150 mg tablet gs- 9350
atazanavir 300 mg capsule
emtricitabine/tenofovir df 200/300 mg tablet Truvada(R)
ritonavir placebo
All drugs will be administered orally, once daily with food at approximately the same time each day.
(Active Comparator)
Ritonavir 100 mg QD + GS-9350 placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 25)
ritonavir 100 mg capsule
atazanavir 300 mg capsule
emtricitabine/tenofovir df 200/300 mg tablet Truvada(R)
gs-9350 placebo
All drugs will be administered orally, once daily with food at approximately the same time each day.

Primary Outcomes

Measure
The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA less than 50 copies/mL at week 24.
time frame: 24 Weeks

Secondary Outcomes

Measure
The secondary efficacy endpoint is the proportion of subjects with HIV-1 RNA less than 50 copies/mL at week 48.
time frame: 48 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Plasma HIV-1 RNA levels greater than or equal to 5,000 copies/mL - No prior use of any approved or experimental anti-HIV drug - Normal ECG - Adequate renal function - Hepatic transaminases less than or equal to 2.5 x upper limit of normal - Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - CD4+ cell count greater than 50 cells/µL - Serum amylase less than or equal to 1.5 x ULN - Normal TSH - Negative serum pregnancy test (females of childbearing potential only) - Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs - Age greater than or equal to 18 years - Life expectancy greater than or equal to 1 year - Ability to understand and sign a written informed consent form Exclusion Criteria: - New AIDS defining condition diagnosed within the 30 days prior to screening - Documented drug resistance to NRTIs, NNRTIs, or primary PI resistance mutation(s) - Hepatitis B surface Antigen (HBsAg) positive - Hepatitis C Antibody positive - Subjects experiencing cirrhosis - Subjects experiencing ascites - Subjects experiencing encephalopathy - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Vaccinated within 90 days of study dosing - History or family history of Long QT Syndrome or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 - Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities - Prolonged QTcF interval at screening (e.g., a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females) - PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening - QRS greater than or equal to 120 msec on ECG at screening - Implanted defibrillator or pacemaker - Subjects receiving ongoing therapy with any disallowed medications - Current alcohol or substance use judged to potentially interfere with subject study compliance - History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline - Participation in any other clinical trial without prior approval - Medications contraindicated for use with atazanavir, ritonavir, emtricitabine, or tenofovir disoproxil fumarate - Any known allergies to the excipients of atazanavir capsules, ritonavir capsules, GS-9350 tablets or Truvada(R) (FTC/TDF) tablets - Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Additional Information

Official title A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Description Double-blinded, multicenter, randomized, active-controlled study to assess the safety and efficacy of a regimen containing ATV/GS-9350 plus FTC/TDF versus ATV/r plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adult subjects. Subjects will be randomized in a 2:1 ratio to one of the following two treatment arms: Treatment Arm 1: GS-9350 150 mg QD + ritonavir placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 50) Treatment Arm 2: Ritonavir 100 mg QD + GS-9350 placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 25) Randomization will be stratified by HIV-1 RNA level (less than or equal to 100,000 copies/mL or greater than 100,000 copies/mL) at screening. After Week 48, subjects will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded, at which point all subjects will return for an Unblinding Visit and will be given the option to participate in an Open-Label Rollover Extension and receive GS-9350-boosted atazanavir, and Truvada® until GS-9350 tablets become commercially available, or until Gilead Sciences elects to terminate the study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Gilead Sciences.