The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Dakar, Senegal.

Condition	Treatment or Intervention
HIV Infections	Drug: Efavirenz  Drug: Lamivudine/zidovudine

Further Study Details: 

Primary Outcomes: Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml measured by Week 24 and confirmed by repeat testing within 30 days; treatment-related toxicity of Grade 3 or higher at any times during the first 24 weeks of treatment
Expected Total Enrollment:  44

Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.

This study will last 96 weeks. At study entry, all study participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires.

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV-1 infected
• Have never taken antiretroviral drugs
• CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
• Viral load of more than 1000 copies/ml within 60 days of study entry
• Willing to stay in the study area for the duration of the study
• Willing to use acceptable forms of contraception
• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• HIV-2 infected
• Major genotypic resistance to any of the first-line drugs, as determined by the protocol team
• Systemic chemotherapy (except interferon) within 6 months prior to study entry
• Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
• Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
• Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
• Have taken certain medications within 30 days of study entry
• Pregnancy or breastfeeding

Study chairs or principal investigators

Souleymane Mboup,  Study Chair,  Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur   

Study ID Numbers:  SN-CIPRA-001
Record last reviewed:  January 2005
Last Updated:  April 1, 2005
Record first received:  January 3, 2005
ClinicalTrials.gov Identifier:  NCT00100568
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08