HIV/bacterial infections Infections and Infestations Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Conditions
Interventions
Sample size:
In the present study it was planned to randomise 400 women and follow them for an average of 18 months on the assumption that there would be a loss of about 20% of women y
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who have recently given birth 2. Aged 16 years or more 3. HIV-seropositive at stage 2 or 3 of the World Health Organization (WHO) staging system for HIV infection 4. Evidence of residence at a permanent address in Lusaka 5. Willing to attend at two-monthly intervals for follow-up 6. Informed written or verbal consent
Exclusion criteria
Exclusion criteria: 1. Current opportunistic infection or currently receiving co-trimoxazole 2. History of sulphonamide allergy 3. Breast feeding women with premature babies 4. Advanced HIV-disease or serious non-HIV disease (i.e. unlikely to survive more than 2 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mortality from any cause or hospital admission, measured at end of trial; all deaths will be recorded as they occur 2. Safety (serious adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence and completion rates, recorded throughout the trial. | — |
Countries
Zambia
Outcome results
None listed