Background
Antiretroviral therapy (ART) in early HIV infection may enhance outcome. ART during acute HIV-1 infection (AI) might better control HIV than ART in recent HIV-1 infection (RI) 24 weeks after treatment interruption.
Methods
A prospective ACTG trial of ART stratified by AI vs. RI. If HIV RNA plasma concentration <50 copies/mL) after >= 52 weeks, ART was interrupted. If viremia rebounded ART and interruption was repeated. The primary endpoint was maintaining plasma HIV RNA concentration < 5,000 copies/mL for 24 weeks following either treatment interruption.
Results
121 subjects were enrolled at 15 sites. The trial was closed in mid-2007. 95% were men, median age was 34 years; 69% were white, 94% reported no injection drug use. Median baseline plasma HIV RNA concentration was higher in AI (210,000 copies/mL) than RI (43,000 copies/mL). The 73 primary endpoint subjects (28 AI, 45 RI) had significantly higher baseline CD4+ T cell counts (p=0.044) and lower HIV RNA plasma concentrations (p=0.016) but did not differ in acuity of infection from those not entering treatment interruption. The primary endpoint was achieved in 29 (40%) of the 73 and in 24% of the 121 enrolled overall. There was no significant outcome difference (p=0.81) between the AI (43%, 95% CI: 24–63%) and RI (38%, 95% CI: 24–53%) groups. Differences after longer follow up can not be ascertained by this trial. Baseline viral load <100,000/mL 22/46 (48%) compared with >100,000/mL, 7/27 (26%) and higher baseline CD4+ immune activation predicted success.
Conclusion
40% of subjects treated during AI or RI sustained an HIV RNA plasma concentration <5,000 copies/mL after 24 weeks of treatment interruption.