Title : Phase II, Parallel, Randomized, Clinical Trials Comparing The Responses To Initiation Of NNRTI-Based Versus PI Based Antiretroviral Therapy In Hiv-Infected Infants Who Have And Have Not Previously Received Single Dose Nevirapine For Prevention Of Mother-To-Child Hiv Transmission

Principal Investigator 

Mutsawashe Bwakura- Dangarembizi, M.D.
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Study Hypothesis

• Prior exposure to NVP for prevention of MTCT selects for resistant strains and compromises subsequent response to NNRTI-based ARV treatment regimens for some HIV-infected infants/children.
• PI-based ARV treatment regimens will possess clear superiority compared with NNRTI-based regimens when initiating therapy in infancy and early childhood, regardless of prior SD NVP exposure.

Study Description

This is a Phase II, randomized, controlled trial of HIV-infected infants and children between 6 months and 36 months of age who are eligible for ART as defined by the WHO pediatric algorithm (CD4% <20% if <18 months of age, or <15% if >18 months of age, or AIDS-defining illness).  Infants/children will be enrolled in one of two cohorts based on NVP exposure.  Within each cohort, they will be randomized to one of two ARV treatment regimens. An equal number of infants/children above and below 12 months of age will be enrolled in each cohort.

Sites

There are sites in South Africa, Tanzania, Uganda, Zambia, Thailand and Zimbabwe.
A total of 576 infants/children will be enrolled and the Zimbabwe site will enroll 100 infants/children.
 
Project Period

The study will run for 3 years and enrollment started on the 13th of  March 2007. The Harare site is at Parirenyatwa??? UZCRC CRS (Family Care Centre). All participants will complete at least 48 weeks of follow-up, continuing on study treatment until 24 weeks from the time the last participant is enrolled. 

Study Contact

Dr  Tapiwa Mbengeranwa ( Medical Officer)
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