A5208

Optimal Combination Therapy After Nevirapine Exposure (OCTANE)

Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID)

Protocol Summary: A5208 was a phase III study that comprised of two randomized clinical trials that were conducted concurrently. Both compared the virologic response to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based versus protease inhibitor (PI)-based antiretroviral treatment (ART) in HIV-infected, treatment-naïve women. Trial 1 evaluated the superiority of PI-based ART over NNRTI-based ART in women with prior single-dose (SD) nevirapine (NVP) prophylaxis for mother-to-child-transmission (MTCT) of HIV. Trial 2 evaluated the equivalence of PI- and NNRTI-based ART in women with no prior NVP exposure.

Years: 2007 – 2011

Investigator: Tsungai Chipato, MBChB, FRCOG, MCE

Location: Parirenyatwa CRS

ACTG

Completed Study

Publication:

Lockman S, Hugues MD, McIntyre J, et al. (2010) Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1499-509.

Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, Chipato T, et al. (2012) Nevirapine-versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLos Med 9(6): e1001236.

Porter KA, Cole SR, Eron JJ Jr, et al. HIV-1 protease inhibitors and clinical malaria: a secondary analysis of the AIDS Clinical Trials Group A5208 study. Antimicrob Agents Chemother. 2012 Feb;56(2):995-1000.

Skinner-Adams TS, Butterworth AS, Porter KA, et al. (2012) The frequency of maleria is similar among women receiving either lopinavir/ritonavir or nevirapine-based antiretroviral treatment. (2012) PLoS One 2012;7(4):e34399.