Safety and Efficacy of GS-9350-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Gilead Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00892437
First received: April 30, 2009
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: 150 mg tablet GS- 9350
Drug: ritonavir 100 mg capsule
Drug: atazanavir 300 mg capsule
Drug: emtricitabine/tenofovir DF 200/300 mg tablet
Drug: ritonavir placebo
Drug: GS-9350 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: June 2009
Estimated Study Completion Date: July 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
GS-9350 150 mg QD + ritonavir placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 50)
Drug: 150 mg tablet GS- 9350 Drug: atazanavir 300 mg capsule Drug: emtricitabine/tenofovir DF 200/300 mg tablet
Other Names:
  • Truvada(R)
  • FTC/TDF
Drug: ritonavir placebo
All drugs will be administered orally, once daily with food at approximately the same time each day.
Active Comparator: 2
Ritonavir 100 mg QD + GS-9350 placebo QD + atazanavir 300 mg QD + single tablet FTC/TDF 200/300 mg QD (n = 25)
Drug: ritonavir 100 mg capsule Drug: atazanavir 300 mg capsule Drug: emtricitabine/tenofovir DF 200/300 mg tablet
Other Names:
  • Truvada(R)
  • FTC/TDF
Drug: GS-9350 placebo
All drugs will be administered orally, once daily with food at approximately the same time each day.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892437

  Show 44 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Steven Chuck, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00892437     History of Changes
Other Study ID Numbers: GS-US-216-0105
Study First Received: April 30, 2009
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
HIV-1
Antiretroviral Treatment-Naive

Additional relevant MeSH terms:
Tenofovir disoproxil
Tenofovir
Ritonavir
Atazanavir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014