HIV/AIDS Malaria
Conditions
Interventions
3TC -d4T-NVP plus AL
3TC-AZT-TDF-LPV/r plus DHA-PQ
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Blantyre City residents 2. Confirmed HIV positive clients a. Controls group (ART naïve): with CD4 Cell count more than 250 cells/mm3 b. Intervention group (ART-treated): with CD4 cell count more than 250 cells/mm3 and receiving first-line, alternative first line or second line ART, as described in the background section, for ¿6 months. 3. Age ¿18 years 4. Ability to read and write and provide informed consent 5. Body weight at least 40kgs (so that they are eligible to receive recommended adult doses of the antimalarial drug) 6. Stated willingness to be contacted by phone or at home. 7. Stated willingness to be admitted in the hospital for 3 days and to remain in Blantyre city for 2 months after enrolment.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index less than 18.5kg/m2 2. CD4 Cell count twice/week), tobacco (>3 times/week) or any use of illicit drugs 6. History or evidence of pre-existing diseases of the liver and kidneys ie if the serum transaminases levels are >3 times the upper limit of normal or urea and creatinine levels >1.5 times the upper limit of normal. 7. History or evidence of heart disease, including conductive abnormalities on electrocardiographs (ECGs) ie QTc interval>450ms (men) and >470ms (females) 8. Clinical and/or laboratory evidence of other infections in addition to HIV, such as clinical malaria or microscopic asexual forms of Pf malaria, hepatitis B, pneumonia, tuberculosis, bacteremia etc. 9. Laboratory evidence of white blood cell disorders such as neutropenia, lymphopenia and thrombocytopenia. 10. Physically unfit with Karnofsky score of <80%. 11. Hypersensitivity to any of the ACTs. 12. Pregnancy ie confirmed by a Human Chorionic Gonadotrophin test. 13. Current participation in any other therapeutic or vaccine trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) for the ACT;adverse events | — |
Countries
Malawi
Contacts
Public ContactDianne Terlouw
Outcome results
None listed