Project no.: A5288 (NCT01641367)
This is a randomized, open labelled, multicentered international study that will assess the efficacy, safety and tolerability of the combinations of new anti-HIV drugs with and without anti-TB drug. This study will also assess whether text messages can help improve adherence or not.
Results: From 2013-2015, 545 participants in 10 countries in Africa, Asia, South America and the Caribbean enrolled: 47% females; median age 41 years, median CD4 count 175 cells/mm3. At enrollment, drug resistance (moderate or high-level) to 0, 1, 2, and 3 ARV classes was identified in 22%, 20%, 30% and 27% of participants, respectively. Overall, 64% (95% CI 60, 68%) had VL ≤ 200 copies/ mL at week 48. Viral suppression and VF differed across cohorts. By week 48, Cohort A had the most Grade ≥ 3 adverse events (39%) and regimen discontinuations (13%). No differences in VL ≤ 200 copies/mL at week 48 or VF ≥ 24 weeks were observed in the randomized comparison of B1 & B2 cohorts.
(Source: Grinsztejn B, et al., Results of ACTG A5288: A strategy study in RLS for 3rd-Line ART candidates. Abstract #30LB. Presented at CROI 2018)
