Status:
UNKNOWN
Cotrimoxazole Prophylaxis Cessation Study Among Stabilized HIV-Infected Adult Patients on HAART in Entebbe, Uganda
Lead Sponsor:
MRC/UVRI and LSHTM Uganda Research Unit
Collaborating Sponsors:
Medical Research Council
Conditions:
HIV Infections
Eligibility:
All Genders
16-59 years
Phase:
PHASE4
Brief Summary
According to the national guidelines in Uganda and to the World Health Organization guidelines, HIV-infected patients should receive cotrimoxazole prophylaxis indefinitely. There are, however, concern...
Detailed Description
Randomized double-blind placebo controlled equivalence trial to be conducted among consenting clinically healthy patients on HAART with 2 or more CD4 counts of 200 cells/ul or more for at least 3 mont...
Eligibility Criteria
Inclusion
- Consenting HIV-infected patient aged 16 years or older,
- Resident within 40 kms of study clinics
- Regularly attending clinics
- Documented HAART intake for at least 3 months
- Clinically healthy and stable
- Confirmed CD4 count of 200 cells/ul more.
Exclusion
- Acutely ill patients with opportunistic or other infections
- Patients already enrolled in other HAART trials (e.g DART trial)
- First trimester pregnancy at enrolment
- Clinical and immunological evidence of HAART treatment failure
- Unable to attend study clinics regularly
- Hypersensitivity to cotrimoxazole
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
1650 Patients enrolled
Trial Details
Trial ID
NCT00674921
Start Date
June 1 2008
End Date
June 1 2011
Last Update
June 5 2008
Active Locations (1)
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1
MRC/UVRI Uganda Research Unit on Aids
Entebbe, Uganda, 256