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

Information source: MRC/UVRI Uganda Research Unit on Aids
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: cotrimoxazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: MRC/UVRI Uganda Research Unit on Aids

Official(s) and/or principal investigator(s):
George Miiro, MSc, MBChB, Principal Investigator, Affiliation: MRC/UVRI Unit
Heiner Grosskurth, PhD, MD, Study Director, Affiliation: MRC/UVRI Unit
Paula Munderi, MRCP, MBChB, Principal Investigator, Affiliation: MRC/UVRI Unit

Overall contact:
George Mukalazi Miiro, MSc, MBChB, Phone: 256-414-320-272, Email: george.miiro@mrcuganda.org

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?

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: all-cause morbidity such as pneumonia or malaria (presumptive and definitive diagnosis)

Secondary outcome: sub-clinical laboratory abnormalities (such as neutropenia) and serious adverse events (such as death)

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 months. The study will enable comparison of effects of randomized cessation of cotrimoxazole prophylaxis at 2 CD4-guided thresholds (200 Vs 350 cells/ul). Rationale for inclusion of the placebo-controlled design

- The double-blind placebo controlled approach is feasible and ethically justified in

this equipoise situation to allow for concealment of allocated intervention among investigators and patients and avoids accidental unblinding of investigators to the allocated interventions by trial patients.

- Maintenance of continued cotrimoxazole prophylaxis among patients randomized to this

intervention will be easier if there is no awareness that those patients randomized to cessation of prophylaxis have a relative advantage of reduced pill burden.

- It would be very difficult to maintain cessation of cotrimoxazole prophylaxis among

patients randomized to do so in our setting where cotrimoxazole is readily and cheaply available in drug shops, drug stores and pharmacies. First randomisation Patients who have been on HAART for at least 3 months and who have a confirmed CD4 count between 200 and 349 cells/ul will be randomized to continue prophylaxis with active cotrimoxazole or to cease prophylaxis with active cotrimoxazole but continue with ingestion of the placebo cotrimoxazole daily. Second randomization Patients who achieve a confirmed CD4 count of 350 cells/ul or more while on HAART will be randomized to continue prophylaxis with active cotrimoxazole or to cease prophylaxis with active cotrimoxazole but continue with ingestion of placebo cotrimoxazole daily. Some patients will have participated already in 1st randomization but others will be entering the trial at this stage for the first time. Rationale for 4 trial arms In order to assess the separate effects of cessation of cotrimoxazole prophylaxis in trial patients at the 2 randomization stages above, those continuing with prophylaxis will be compared with those ceasing prophylaxis, necessitating 2 arms at each stage.

Eligibility

Minimum age: 16 Years. Maximum age: 59 Years. Gender(s): Both.

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

Locations and Contacts

George Mukalazi Miiro, MSc, MBChB, Phone: 256-414-320-272, Email: george.miiro@mrcuganda.org

MRC/UVRI Uganda Research Unit on Aids, Entebbe 256, Uganda
Additional Information

Starting date: June 2008
Last updated: June 4, 2008

Page last updated: August 23, 2015

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