Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria (CoTrimResist)
HIV-1-infection, Pneumocystis Pneumonia, Opportunistic Infections
About this trial
This is an interventional prevention trial for HIV-1-infection focused on measuring Microbial drug resistance, Beta-lactamase, Cotrimoxazole, Trimethoprim-sulfamethoxazole, Tanzania
Eligibility Criteria
Inclusion Criteria:
- Only patients who provide written informed consent will be included
- Patients aged 18 years or older with newly diagnosed HIV-infection and CD4 counts of โฅ 350 per microliter will be included for randomisation to receive placebo or cotrimoxazole preventive treatment.
- Persons testing hiv negative at the participating clinics will be included as additional control group but not randomised to interventions
- Persons testing hiv-positive and having impaired immunity with CD4 count below will be included as additional control group but not randomised for intervention. This group will routinely receive cotrimoxazole prophylaxis from the national AIDS control program, and not followed-up further in this study.
Exclusion Criteria:
- CD4<350 per microliter at enrollment
- Patients allergic to cotrimoxazole
- Children under age of 18 years
- Pregnant women
Sites / Locations
- Amana Regional Referral Hospital
- Mbagala District Hospital
- Mnazimmoja Health Centre
- Mwananyamala Regional Referral Hospital
- Pasada Upendano
- Temeke Regional Referral Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Cotrimoxazole
Placebo
Patients in the Cotrimoxazole study arm will receive 2 tablets daily of Cotrimoxazole (trimethoprim 80mg + sulfamethoxazole 400mg), these tablets are purchased locally in Tanzania, and are the same as used for pneumocystis preventive therapy under the National AIDS control programme.
Participants in the Placebo arm will receive 2 placebo tablets daily. These tablets have been manufactured by Kragero Tablettproduksjon AS, Norway, and care has been taken to make them look as similar as possible to the locally purchased cotrimoxazole tablets from Tanzania. Neither study participants, care providers, investigators or outcome assessors will know which patients receive cotrimoxazole or placebo