NL-OMON42500撤回3 期
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 - Gilead GS-US-366-1160
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •* 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
研究者
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