Study of Options for Second-Line Effective Combination Therapy (SELECT)
Summary
The study was conducted on people who were taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen were not doing a good job of fighting their HIV infection. The main purpose of this study was to compare two other anti-HIV drug regimens to see how well they fight HIV. The study also looked at how well participants tolerate the drug regimens and how safe they are. The study was designed to determine whether taking the combination of lopinavir/ritonavir (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination. Testing a regimen that does not include any NRTIs was important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.
Timeline
- Start
- 2012-03-13
- Primary completion
- 2014-10-29
- Completion
- 2014-10-29
Publications
- Background [1] Hull M, Moore D, Harris M, et al. A lamivudine (3TC)-based backbone in conjunction with a boosted protease inhibitor (PI) is sufficient to achieve virologic suppression in the presence of M184V mutations. Program and abstracts of the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12-15, 2009; San Francisco, California. Abstract H-916.
- Torres TS, Harrison LJ, La Rosa AM, Zheng L, Cardoso SW, Ulaya G, Akoojee N, Kadam D, Collier AC, Hughes MD; for AIDS Clinical Trials Group (ACTG) A5273 Study Group. Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings. AIDS Care. 2021 Oct;33(10):1340-1349. doi: 10.1080/09540121.2021.1874275. Epub 2021 Jan 23.
- La Rosa AM, Harrison LJ, Taiwo B, Wallis CL, Zheng L, Kim P, Kumarasamy N, Hosseinipour MC, Jarocki B, Mellors JW, Collier AC; ACTG A5273 Study Group. Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV. 2016 Jun;3(6):e247-58. doi: 10.1016/S2352-3018(16)30011-X. Epub 2016 Apr 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 300 mg | Oral |
| Subject | Abacavir | Other / unclassified | 600 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 150 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Subject | Lopinavir | Other / unclassified | 400 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | Zidovudine | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |