Micronutrient supplementation of HIV-1-infected children Infections and Infestations Human Immunodeficiency Virus (HIV)
Conditions
Interventions
Patients are randomised into one of the three arms:
Group A - placebo
Group B - trace element supplement
Group C - high dose zinc supplement (3 mg/kg elemental zinc)
Trial drugs are given orally dail
Sponsors
Secure-The-Future Bristol-Myers Squibb (South Africa)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically stable (not acutely ill) 2. Vertically transmitted HIV-1 infected children 3. Attending the Infectious Diseases Clinic at Red Cross Children's Hospital 4. Aged six months to six years
Exclusion criteria
Exclusion criteria: 1. HIV-infected children aged less than six months 2. Children with an intercurrent infection or axillary temperature of more than 38°C 3. Children with any invasive opportunistic infection including tuberculosis 4. Children with bronchiectasis 5. Children who had received high dose vitamin A, trace elements or zinc supplements within the preceding eight weeks 6. Children recently hospitalised within the preceding six weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative frequency of adverse or serious infective episodes, or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Viral load and CD4 count changes 2. Biochemical variables such as micronutrient levels measures 3. Relative frequency of minor infective episodes | — |
Countries
South Africa
Outcome results
None listed