drugset / Trial / NCT00855413
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
Phase 4
Terminated
15 enrolled
University of North Carolina, Chapel Hill
Janssen Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine, Optional studies: Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy
Timeline
- Start
- 2009-03
- Primary completion
- 2013-11
- Completion
- 2013-11
Publications
- Background Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 2011 Apr 24;25(7):941-9. doi: 10.1097/QAD.0b013e3283463c07.
- Background C Gay, O Dibben, A Stacey, N Gasper-Smith, M Liu, N Goonetilleke, G Ferrari, J Eron, C Hicks, A McMichael, B Haynes, P Borrow, M Cohen, the Duke-UNC CHAVI 001 Clinical Working Group. "Effect(s) of antiretroviral treatment on acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0086.
- Gay CL, Neo DT, Devanathan AS, Kuruc JD, McGee KS, Schmitz JL, Sebastian J, Shaheen NJ, Ferrari G, McKellar M, Fiscus SA, Hicks CB, Robertson K, Kashuba ADM, Eron JJ, Margolis DM. Efficacy, pharmacokinetics and neurocognitive performance of dual, NRTI-sparing antiretroviral therapy in acute HIV-infection. AIDS. 2020 Nov 1;34(13):1923-1931. doi: 10.1097/QAD.0000000000002652.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | Oral |
| Subject | Etravirine | Small molecule | 400 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |