Status:
COMPLETED
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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 subtyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00100568
Start Date
July 1 2006
End Date
June 1 2009
Last Update
September 6 2013
Active Locations (2)
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1
Centre National Hospitalier de Fann, Dakar CIPRA CRS
Dakar, Senegal
2
Institut d'Hygiène Sociale, Dakar CIPRA CRS
Dakar, Senegal