Chronic human immunodeficiency virus (HIV) infection Infections and Infestations Human immunodeficiency virus
Conditions
Interventions
Patients who fulfil the inclusion criteria and who do not meet exclusion criteria will be recruited sequentially and will be randomised 1:1 to the experimental or control group:
1. Exp
Sponsors
MRC/UVRI Uganda Research Unit on AIDS (Uganda)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy: time to the occurrence of the first clinical event (pre-defined CTX-preventable opportunistic clinical event or death) 2. Safety: time to the occurrence of the first grade 3 or 4 haematological adverse event Recorded at first occurrence during the trial and assessed at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of all CTX preventable events, recorded at time of occurrence 2. All cause mortality, recorded at time of occurrence 3. Incidence of all clinical events and related events requiring hospitalisation, recorded at time of occurrence 4. Incidence of all confirmed malaria episodes* asymptomatic and symptomatic, recorded at time of occurrence 5. Severity and outcome of all confirmed malaria episodes* asymptomatic and symptomatic, recorded at time of occurrence 6. Incidence of grade 3 or grade 4 adverse events, recorded at time of occurrence 7. Mean change in CD4 count after 12 months on the trial 8. Mean change in haematologic indices after 12 months on the trial 9. Serious adverse events (SAEs)-according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) definitions, recorded at time of occurrence 10. Adherence to use of ART, trial drug and insecticide-treated mosquito nets, evaluated at end of trial * confirmed by positive parasitaemia on a blood slide | — |
Countries
Uganda
Outcome results
None listed