Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women - Full Text View

Purpose

To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV 1 RNA <50 copies/mL at Week 48

Condition	Intervention	Phase
Acquired Immunodeficiency Syndrome HIV Infections	Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df Drug: ritonavir + atazanavir + 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) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

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

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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

Secondary Outcome Measures:

To evaluate the change 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 48

Estimated Enrollment:	510
Study Start Date:	October 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir df Single tablet regimen of elvitegravir 150 mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + placebos to match ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200mg/tenofovir disoproxil fumarate 300 mg once daily	Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single table regimen administered orally with food once daily
Active Comparator: ritonavir + atazanavir + emtricitabine/tenofovir df Ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg once daily	Drug: ritonavir + atazanavir + emtricitabine/tenofovir df ritonavir 100 mg + atazanavir 300 mg + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg administered orally with food once daily Other Names: Truvada® Norvir® Reyataz® Stribild®

Detailed Description:

Randomized, double-blinded, multicenter, active-controlled study to evaluate the safety and efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) administered as a single tablet regimen (STR) versus ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (Truvada® or FTC/TDF) in HIV 1 infected, antiretroviral treatment-naïve adult women.

Eligibility

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

Criteria

Inclusion Criteria:

Female (at birth), age ≥ 18 years
Ability to understand and sign a written informed consent form
Plasma HIV-1 RNA levels ≥500 copies/mL
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir boosted with ritonavir (ATV/r)
Normal ECG
Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL
Adequate hematologic function
Serum amylase ≤ 5 x ULN
Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
Women who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.

Exclusion Criteria:

A new AIDS defining condition diagnosed within the 30 days
Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Have an ECG PR interval ≥ 220 msec
Current alcohol or substance use which may potentially interfere with subject study compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
Participation in any other clinical trial without prior approval
Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
Subjects receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF, ATV, RTV; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, Truvada® tablets, atazanavir capsules or ritonavir tablets

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705574

Contacts

Contact: Anne Thomas

(650) 372-7998

Anne.Thomas@gilead.com

Show 70 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Huyen Cao, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01705574 History of Changes
Other Study ID Numbers:	GS-US-236-0128, 2012-003708-11
Study First Received:	October 10, 2012
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

HIV-1
HIV
Treatment-Naïve
Women
WAVES

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
HIV Protease Inhibitors
Anti-HIV Agents
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir

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

ClinicalTrials.gov processed this record on May 19, 2013

Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women (WAVES)