Cotrimoxazole Prophylaxis Cessation Study Among Stabilized HIV-Infected Adult Patients on HAART in Entebbe, Uganda (CCS)
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Opportunistic Infections, AIDS, HIV, Treatment Experienced
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- MRC/UVRI Uganda Research Unit on Aids
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
1
2
A
B
It will comprise patients randomized to receive the placebo (stop cotrimoxazole prophylaxis) at CD4 counts of 200 or more but less than 350 cells/ul as they continue with HAART. Patients will be followed until they achieve a CD4 count of 350 cells/ul.
It will comprise patients randomized to continue with cotrimoxazole prophylaxis and HAART at CD4 counts of 200 or more but less than 350 cells/ul. These patients will be followed until they achieve a CD4 count of 350 cells/ul and above, at which point they will be considered for the second randomization.
This arm will comprise patients who have achieved a CD4 count of 350 or more cells/ul either at the beginning of the study or once they have reached this threshold at the end of follow up in arms 1 and 2. They (including those previously in Arm 1) will receive the placebo (stop cotrimoxazole prophylaxis) after the second randomization but continue with HAART.
It will comprise patients randomized to continue or start with cotrimoxazole prophylaxis and HAART at CD4 of 350 or more cells/ul after second randomization. Some of them will have used cotrimoxazole prophylaxis whilst they were in arm 2 and others in arm 1 will restart cotrimoxazole prophylaxis at this stage.