Trials / Withdrawn
WithdrawnNCT03405194
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
An Open-Label, Randomized Comparison of Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine Versus Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine in Patients Starting Antiretroviral Therapy on the Day of HIV Diagnosis
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Detailed description
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elvitegravir, Cobicistat, TAF, FTC | Started on day of HIV diagnosis |
| DRUG | Efavirenz, TDF, and 3TC | Started on day of HIV diagnosis |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-07-01
- First posted
- 2018-01-23
- Last updated
- 2020-03-18
Source: ClinicalTrials.gov record NCT03405194. Inclusion in this directory is not an endorsement.