Status:
COMPLETED
Response to Standard HIV Treatment in Bamako, Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National...
Detailed Description
This study will assess the efficacy of HIV treatment provided in accordance with the Malian National HIV Treatment Program. The Malian National HIV Treatment Program uses fixe dose coninaison (FDC) th...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- HIV-infected adults (age greater than or equal to 18 years) naive to treatment with antiretroviral medications, who are to begin the regimen of government-sponsored antiretroviral treatment program or an alternate regimen in the case of HIV1 and HIV2 coinfected individuals.
- The sole exception to naive will be a history of use of peripartum single-dose nevirapine.
- Hemoglobin greater than or equal to 8 g/dL
- Ability and willingness to provide informed consent and ability to comply with study requirements and visit schedule.
- Must be willing to allow stored samples to be used in the future for studying HIV disease and immune function.
- EXCLUSION CRITERIA:
- Serologic evidence of HIV-2 infection mono-infection.
- Tuberculosis of any form for which the patient is currently undergoing treatment with or requires a recommended regimen containing a rifamycin antibiotic.
- Baseline medical conditions that preclude the use of the Malian fixed-dose regimen, such as peripheral neuropathy of any etiology and pancreatic disease.
Exclusion
Key Trial Info
Start Date :
June 18 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00703404
Start Date
June 18 2008
End Date
February 24 2016
Last Update
April 5 2018
Active Locations (1)
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1
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako, Mali