Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults - Full Text View

Sponsor:	Gilead Sciences
Information provided by (Responsible Party):	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01106586

Purpose

To evaluate the safety and efficacy of a single tablet regimen containing fixed doses of EVG/FTC/TDF/GS-9350 versus ritonavir-boosted atazanavir plus standard of care NRTI backbone of FTC/TDF. Ritonavir-boosted atazanavir was selected as the active comparator for this study as it is one of the treatment guidelines' preferred PIs for treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Condition	Intervention	Phase
HIV Infections	Drug: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Drug: ritonavir and atazanavir and emtricitabine /tenofovir DF	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Ritonavir Atazanavir Tenofovir Disoproxil Fumarate Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary efficacy endpoint is the proportion of subjects that achieve HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
The change from baseline in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The change from baseline in CD4+ cell count at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment:	708
Study Start Date:	April 2010
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Fixed-dose combination tablet of elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS-9350 + Placebos to match ritonavir and atazanavir and emtricitabine/tenofovir disoproxil fumarate QD (n = 350)	Drug: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Fixed-dose combination tablet of elvitegravir 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg/GS-9350 150 mg + Placebos to match ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg QD (n = 350)
Active Comparator: ritonavir and atazanavir and emtricitabine /tenofovir DF ritonavir and atazanavir and emtricitabine/tenofovir disoproxil fumarate + Placebo to match fixed-dose combination tablet of elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS-9350 QD (n = 350)	Drug: ritonavir and atazanavir and emtricitabine /tenofovir DF ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + Placebo to match fixed-dose combination tablet of elvitegravir 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg/GS-9350 150 mg QD (n = 350)

Eligibility

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

Criteria

Inclusion Criteria:

Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to FTC, TDF, and ATV
Normal ECG
Adequate renal function
Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 x ULN
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 drug
Age ≥ 18 years
Life expectancy ≥ 1 year

Exclusion Criteria:

A new AIDS defining condition diagnosed within the 30 days prior to screening
Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Implanted defibrillator or pacemaker
Have an ECG PR interval ≥ 220 msec
Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, 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
Medications contraindicated for use with elvitegravir (EVG), GS-9350, emtricitabine (FTC),tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of EVG/FTC/TDF/GS-9350 tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets
Participation in any other clinical trial without prior approval
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106586

Show 213 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Alena Jandourek, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01106586 History of Changes
Other Study ID Numbers:	GS-US-236-0103
Study First Received:	April 14, 2010
Last Updated:	October 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

HIV 1 Infection
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Atazanavir
Tenofovir disoproxil

Tenofovir
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012