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Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230.

Publication ,  Journal Article
Kumarasamy, N; Aga, E; Ribaudo, HJ; Wallis, CL; Katzenstein, DA; Stevens, WS; Norton, MR; Klingman, KL; Hosseinipour, MC; Crump, JA ...
Published in: Clin Infect Dis
May 15, 2015

BACKGROUND: The AIDS Clinical Trials Group (ACTG) A5230 study evaluated lopinavir/ritonavir (LPV/r) monotherapy following virologic failure (VF) on first-line human immunodeficiency virus (HIV) regimens in Africa and Asia. METHODS: Eligible subjects had received first-line regimens for at least 6 months and had plasma HIV-1 RNA levels 1000-200 000 copies/mL. All subjects received LPV/r 400/100 mg twice daily. VF was defined as failure to suppress to <400 copies/mL by week 24, or confirmed rebound to >400 copies/mL at or after week 16 following confirmed suppression. Subjects with VF added emtricitabine 200 mg/tenofovir 300 mg (FTC/TDF) once daily. The probability of continued HIV-1 RNA <400 copies/mL on LPV/r monotherapy through week 104 was estimated with a 95% confidence interval (CI); predictors of treatment success were evaluated with Cox proportional hazards models. RESULTS: One hundred twenty-three subjects were enrolled. Four subjects died and 2 discontinued prematurely; 117 of 123 (95%) completed 104 weeks. Through week 104, 49 subjects met the primary endpoint; 47 had VF, and 2 intensified treatment without VF. Of the 47 subjects with VF, 41 (33%) intensified treatment, and 39 of 41 subsequently achieved levels <400 copies/mL. The probability of continued suppression <400 copies/mL over 104 weeks on LPV/r monotherapy was 60% (95% CI, 50%-68%); 80%-85% maintained levels <400 copies/mL with FTC/TDF intensification as needed. Ultrasensitive assays on specimens with HIV-1 RNA level <400 copies/mL at weeks 24, 48, and 104 revealed that 61%, 62%, and 65% were suppressed to <40 copies/mL, respectively. CONCLUSIONS: LPV/r monotherapy after first-line VF with FTC/TDF intensification when needed provides durable suppression of HIV-1 RNA over 104 weeks. CLINICAL TRIALS REGISTRATION: NCT00357552.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

May 15, 2015

Volume

60

Issue

10

Start / End Page

1552 / 1558

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Ritonavir
  • RNA, Viral
  • Plasma
  • Pilot Projects
  • Middle Aged
  • Microbiology
  • Male
 

Citation

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MLA
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Kumarasamy, N., Aga, E., Ribaudo, H. J., Wallis, C. L., Katzenstein, D. A., Stevens, W. S., … Bartlett, J. A. (2015). Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230. Clin Infect Dis, 60(10), 1552–1558. https://doi.org/10.1093/cid/civ109
Kumarasamy, Nagalingeswaran, Evgenia Aga, Heather J. Ribaudo, Carole L. Wallis, David A. Katzenstein, Wendy S. Stevens, Michael R. Norton, et al. “Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230.Clin Infect Dis 60, no. 10 (May 15, 2015): 1552–58. https://doi.org/10.1093/cid/civ109.
Kumarasamy N, Aga E, Ribaudo HJ, Wallis CL, Katzenstein DA, Stevens WS, et al. Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230. Clin Infect Dis. 2015 May 15;60(10):1552–8.
Kumarasamy, Nagalingeswaran, et al. “Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230.Clin Infect Dis, vol. 60, no. 10, May 2015, pp. 1552–58. Pubmed, doi:10.1093/cid/civ109.
Kumarasamy N, Aga E, Ribaudo HJ, Wallis CL, Katzenstein DA, Stevens WS, Norton MR, Klingman KL, Hosseinipour MC, Crump JA, Supparatpinyo K, Badal-Faesen S, Bartlett JA. Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230. Clin Infect Dis. 2015 May 15;60(10):1552–1558.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

May 15, 2015

Volume

60

Issue

10

Start / End Page

1552 / 1558

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Ritonavir
  • RNA, Viral
  • Plasma
  • Pilot Projects
  • Middle Aged
  • Microbiology
  • Male