drugset / Trial / NCT01641367
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
Phase 4
Completed
545 enrolled
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
AbbVie · collabDimagi Inc. · collabGilead Sciences · collabJanssen Pharmaceuticals · collabMerck Sharp & Dohme LLC · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study was done to: * test a strategy of using a resistance test to choose anti-HIV drugs * see how well combinations of new anti-HIV drugs work to lower HIV infection * see if taking new anti-HIV drugs together is safe and tolerable * see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study) * in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body * to see how people do after they stop having frequent clinic visits as part of a research study
Timeline
- Start
- 2013-02-22
- Primary completion
- 2016-11-23
- Completion
- 2018-12-31
Publications
- Avihingsanon A, Hughes MD, Salata R, Godfrey C, McCarthy C, Mugyenyi P, Hogg E, Gross R, Cardoso SW, Bukuru A, Makanga M, Badal-Aesen S, Mave V, Ndege BW, Fontain SN, Samaneka W, Secours R, Van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Munyanga C, Chagomerana M, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC, Grinsztejn B; A5288 Study team. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. J Int AIDS Soc. 2022 Jun;25(6):e25905. doi: 10.1002/jia2.25905.
- Godfrey C, Hughes MD, Ritz J, Coelho L, Gross R, Salata R, Mngqibisa R, Wallis CL, Mumbi ME, Matoga M, Poongulali S, Van Schalkwyk M, Hogg E, Fletcher CV, Grinsztejn B, Collier AC; A5288 team. Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):203-207. doi: 10.1097/QAI.0000000000002324.
- Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Godfrey C, Wallis CL, Mellors JW, Mudhune VO, Badal-Faesen S, Grinsztejn B, Collier AC. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digit Health. 2019 May;1(1):e26-e34. doi: 10.1016/S2589-7500(19)30006-8. Epub 2019 May 6.
- Grinsztejn B, Hughes MD, Ritz J, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Gross R, Godfrey C, Cardoso SW, Bukuru A, Makanga M, Faesen S, Mave V, Wangari Ndege B, Nerette Fontain S, Samaneka W, Secours R, van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Avihingsanon A, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC; A5288 Team. Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study. Lancet HIV. 2019 Sep;6(9):e588-e600. doi: 10.1016/S2352-3018(19)30146-8. Epub 2019 Jul 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 600 mg | Oral |
| Subject | Emtricitabine/tenofovir disoproxil fumarate | Unknown | 200 mg | Oral |
| Subject | Emtricitabine/tenofovir disoproxil fumarate | Unknown | 300 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |
| Background | Atazanavir/ritonavir | Unknown | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Lopinavir/ritonavir | Unknown | — | — |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | Tenofovir | Small molecule | — | — |
| Background | Zidovudine | Small molecule | — | — |
| Background | emtricitabine | Other / unclassified | — | — |