Safety of discontinuing co-trimoxazole prophylaxis among Ugandan adults on antiretroviral therapy (ART)

Not Applicable

Completed

• Conditions: Chronic human immunodeficiency virus (HIV) infection; Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN44723643
• Lead Sponsor: MRC/UVRI Uganda Research Unit on AIDS (Uganda)

Brief Summary

2016 Incidence of malari results in: https://www.ncbi.nlm.nih.gov/pubmed/26558729 2016 Longitudinal effect results in: https://www.ncbi.nlm.nih.gov/pubmed/27417903 2017 Effect of antiretroviral therapy results in: https://www.ncbi.nlm.nih.gov/pubmed/28121670 2020 immunology substudy results in https://pubmed.ncbi.nlm.nih.gov/31714954/ (added 17/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-27
• Study Completion: 2014-03-30
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Human immunodeficiency virus (HIV) infected patient taking co-trimoxazole for at least 6 months
2. Aged 18 - 59 years, either sex
3. Documented intake of ART for at least 6 months
4. Clinically asymptomatic
5. Two CD4 counts (not more than 6 months apart) greater than or equal to 250 cells/mm3, the most recent no more than 4 weeks prior to enrolment
6. Able to attend 3-monthly study clinics for appointments and in event of intercurrent illness

Exclusion Criteria

1. Acute illness (opportunistic infection or other co- morbidity). Patients will be considered for inclusion into the trial after resolution of the illness.
2. First trimester pregnancy. Pregnant women who reach their second trimester of pregnancy could then be re-evaluated for inclusion into the trial.
3. Known hypersensitivity to co-trimoxazole

Study & Design

• Study Type: Interventional
• Study Design: Not specified