Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Zidovudine

Criteria

Inclusion Criteria:

• HIV-infected

• Have never taken ARV 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

• Willing to stay in the study area for the duration of the study

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• HIV-2 infected

• 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