Study Title: A Phase IV, Prospective,Randomised, Open Label Evaluation Of The Efficacy Of Once Daily Protease Inhibitor-And Once Daily Non Nucleoside Reverse Transcriptase Inhibitor Containing Therapy Combinations For Initial Treatment Of HIV-1 Infected Individuals From Resource Limited Settings

Sponsor: Division of AIDS, U S. National Institute of Allergy and Infectious Diseases, Boehringer-Ingelheim Pharmaceuticals, Inc. Bristol –Myers Squibb, Gilead Sciences, Inc.and GlaxoSmithKline & Co.,Inc.

Principal Investigator

Professor James G Hakim 
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Study Summary

The purpose of the study is to demonstrate the non-inferiority of a once daily PI- and a once daily NNRTI- containing regimen as compared to a standard twice daily ARV therapy for the initial treatment of individuals infected with HIV-1 who are above the age of eighteen years.

In this Phase IV, open label, randomized, three arm, multi center trial, a total of 1520 HIV infected individuals who are ART naïve and have a CD4 count < 300 cells/ml will be enrolled and randomized into three antiretroviral (ARV) regimens.

In Zimbabwe the study is being conducted in Harare at the University of Zimbabwe, Clinical Research Centre, Parirenyatwa Hospital Annexe. A total of 110 participants have been enrolled and will be followed up until July 2008.

The following sites will also participate in the study; Blantyre and Lilongwe in Malawi, Durban and Johanesburg in South Africa, Chenai in India, Rio de Janeiro in Brazil, Haiti in the Caribbean and the United States of America.

The primary treatment comparisons in this study, will investigate:

 1). If a once daily   regimen containing two nucleoside reverse transcriptase inhibitors (NRTIs) + an HIV-1 protease inhibitor (PI) (ARM 1B) is not inferior to a twice daily regimen that contains two NRTIs + NNRTI (ARM 1A).

 2). If a once daily regimen containing two NRTIs + a non-nucleoside reverse transcriptase inhibitor (NNRTI) (ARM 1C) is not inferior to a twice daily regimen that also contains two NRTIs + NNRTIs (ARM 1A).

Both evaluations will be based on the primary study endpoint - time to treatment failure of the initial regimen (STEP1). Participants who experience virologic failure with the initial treatment may receive a second ARV regimen (STEP2).

Study Contacts

• Dr Wadzanai Samaneka (Research Medical Officer)
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• Rachel Mahachi (Study Coordinator)
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Sponsor: Division of AIDS, U S. National Institute of Allergy and Infectious Diseases, Boehringer-Ingelheim Pharmaceuticals, Inc. Bristol –Myers Squibb, Gilead Sciences, Inc.and GlaxoSmithKline & Co.,Inc.