Phase 3
Completed N=583
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
Acquired Immunodeficiency Syndrome · HIV
Source: ClinicalTrials.gov NCT01705574 ↗
Enrolled (actual)
583
Serious AEs
8.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm — 87.2; 80.8 percentage of participants — p=0.034
Summary
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm |
87.2; 80.8 | 0.034 sig |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase |
221; 212 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm |
84.5 | — |
| SECONDARY Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase |
94.3; 86.8 | — |
| SECONDARY Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase |
265; 35; 49 | — |
Eligibility Criteria
Key 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 (ATV) boosted with ritonavir (RTV)
- 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.
Key Exclusion Criteria
- A new AIDS defining condition diagnosed within the 30 days
- Females receiving drug treatment for Hepatitis C, or females who are anticipated to receive treatment for Hepatitis C during the course of the study
- Females experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Have an implanted defibrillator or pacemaker
- Have an ECG pulse rate interval ≥ 220 msec
- Current alcohol or substance use which may potentially interfere with the female's 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 female unsuitable for the study or unable to comply with the dosing requirements
- Females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01705574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.