drugset / Trial / NCT00014937
Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
RandomizedFactorialOpen-labelTreatment
Summary
ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.
Timeline
- Start
- —
- Primary completion
- 2004-12
- Completion
- —
Publications
- Background Demeter LM, Ribaudo HJ, Erice A, Eshleman SH, Hammer SM, Hellmann NS, Fischl MA; AIDS Clinical Trials Group Protocol 388. HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388. Clin Infect Dis. 2004 Aug 15;39(4):552-8. doi: 10.1086/422518. Epub 2004 Jul 30.
- Results Tebas P, Zhang J, Yarasheski K, Evans S, Fischl MA, Shevitz A, Feinberg J, Collier AC, Shikuma C, Brizz B, Sattler F; AIDS Clinical Trials Group (ACTG). Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s). J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):193-200. doi: 10.1097/QAI.0b013e318042e204.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Didanosine | Small molecule | — | — |
| Subject | Efavirenz | Other / unclassified | 600 mg | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Lopinavir | Other / unclassified | 533 mg | — |
| Subject | Ritonavir | Other / unclassified | 133 mg | — |
| Subject | Stavudine | Other / unclassified | — | — |
| Subject | Zidovudine | Small molecule | — | — |