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OPTIMAL COMBINATION THERAPY AFTER NEVIRAPINE EXPOSURE (OCTANE) STUDY
HIV Overview | HIV Programs

Since the HIVNET 012 demonstrated the efficacy of single dose Nevirapine (SD NVP) in the prevention of mother to child transmission (PMTCT) of HIV, nevirapine has become the logical choice for PMTCT in many settings in developing countries.  Increasingly over the past ½ decade, an intensive scale up program for PMTCT using SD NVP has initiated by government and international agencies in an effort to stem the spread of HIV from mother to child.  SD NVP PMTCT was considered ideal for low resource settings since it was easy to administer, at least 50% efficacious, safe, and affordable, and did not require complex antenatal care for administration.  The down side of this program was the discovery that between 25 -75% of people developed resistance from exposure to SD NVP.  NVP pharmacokenetic studies in healthy volunteers have demonstrated that following SD administration, detectable NVP blood levels persisted for more than 21 days.  As approaching trough and undetectable levels, continued HIV multiplication in the presence of such low NVP levels led to the development of NVP resistance (Muro et al. 11th Retrovirus Conf, Feb 2004 (Abs 891).

While it has been demonstrated that the resistance to NVP fades and can not be detected at 12 to 24 months after exposure using standard testing techniques, several studies have demonstrated residual NVP resistance (minor variants) using more sensitive techniques. The Optimal Combination Therapy After Nevirapine Exposure (OCTANE) study in short will systematically evaluate the clinical significance of SD NVP related resistance in women who proceed to need triple ARV including NVP. 

A5208/OCTANE is a phase III study comprising two randomized clinical trials (RCT) to be conducted concurrently.  Both trials will compare the virologic response to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (Arm 1A) versus protease inhibitor (PI)-based (Arm 1B) antiretroviral treatment (ART) in HIV-infected treatment-naïve women.  Trial 1 will evaluate 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 will evaluate the equivalence of PI- and NNRTI-based ART in women with no prior NVP exposure.  The study will last for approximately 2 years (1 year of accrual across 10 sites in Africa and at least 48 weeks of follow-up after the last subject is enrolled).  A total of 640 subjects will be enrolled.  It is estimated that the Kericho site will enroll approximately 60.

The study is expected to offer better care for patients through reduced costs, dedicated staff, and close follow up and monitoring.  The study will also provide science and technology transfer through human capacity development, infrastructure development, early experience with newer drugs, and early experience with newer tests. Above all, it will answer a critically important scientific question regarding SD NVP, PMTCT, and ARV therapy in developing countries.  The study is anticipated to open in early 2006.

OCATNE team members and family from Rockville, Kericho, and  San Diego at a post-training reception

 

 

 

 

 

 

 

 
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