Cotrimoxazole Prophylaxis Cessation Study Among Stabilized HIV-Infected Adult Patients on HAART in Entebbe, Uganda

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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, concerns regarding the indefinite application of cotrimoxazole prophylaxis among patients immunologically stabilized on HAART (e.g. high pill burden, drug-drug interactions, toxicity and poor adherence because of treatment fatigue). To date no empirical evidence is available regarding the safety and optimal timing for the cessation of cotrimoxazole prophylaxis among HAART patients who successfully restored immunological competence.

Research question: Does morbidity significantly differ between continuation (orthodox) and cessation (experimental) of cotrimoxazole prophylaxis among immuno-competent patients stable HAART in the resource-limited setting of Uganda?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MRC/UVRI and LSHTM Uganda Research Unit; MRC/UVRI Uganda Research Unit on Aids
• Collaborator: Medical Research Council
• Treatments: Trimethoprim, Sulfamethoxazole Drug Combination

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