A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects
- Conditions
- Human Immunodeficiency visrus (HIV-1) infections10047438
- Registration Number
- NL-OMON42500
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Medically stable HIV-1 infected subjects who meet the following criteria:
* Currently receiving antiretroviral therapy consisting only of EFV/FTC/TDF FDC (Atripla) continuously for * 6 months preceding the Screening visit
* Documented plasma HIV 1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for * 6 months preceding the Screening visit. Unconfirmed virologic elevation of * 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or *blip*) and prior to screening is acceptable
* HIV-1 RNA < 50 copies/mL at the Screening visit
* Adequate renal function defined as having an estimated glomerular filtration rate (eGFR) * 50 mL/min as calculated by the Cockcroft Gault
* Have no documented resistance to any of the study agents at any time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R)
* Hepatitis B surface antigen (HBsAg) negative
* Hepatitis C antibody positive with detectable HCV RNA (subjects who have HCV antibody but no detectable HCV RNA are eligible to enroll) No anticipated need to initiate prohibited medications during the study
* Subjects receiving ongoing therapy with any of the specified
medications in the protocol, including drugs not to be used with FTC,
RPV and/or TAF (refer to the individual agents Prescribing Information);
or subjects with any known allergies to the excipients of FTC/RPV/TAF
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>Adverse events and clinical laboratory tests and DXA<br /><br><br /><br>Efficacy:<br /><br>The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA < 50<br /><br>copies/mL at Week 48 as defined by the Food and Drug Administration (FDA)<br /><br>snapshot algorithm.<br /><br><br /><br>Pharmacokinetics:<br /><br>The pharmacokinetics of TAF and RPV will be assessed. The PK of FTC and /or TFV<br /><br>may be explored</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>*The change from baseline in CD4+ cell count at Week 48.</p><br>