Treatment Options for Protease Inhibitor-exposed Children (NEVEREST-III)
HIV/AIDS, HIV Infections
About this trial
This is an interventional treatment trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- HIV-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of Neverest II.
- Reliable history or documented exposure to NVP used as part of PMTCT
- Initiated antiretroviral therapy with LPV/r at age less than 36 months
- Receiving LPV/r-based ART for at least 12 months
- At least one viral load measurement less than 50 copies/ml conducted as part of screening for the study
- ALT measurement grade I or less (DAIDS Toxicity Tables 2004) (Appendix A). These may be repeated until ALTs normalize if necessary.
Exclusion criteria:
- Prior treatment with any NNRTI drug as part of a therapeutic regimen
- Substitution of other NRTI drugs (instead of 3TC and D4T which are the standard first line regimen) will be allowed.
Sites / Locations
- Rahima Moosa Mother and Child Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
Group 1: Lopinavir/ritonavir (LPV/r)
Group 2: Efavirenz (EFV)
Group D: Stavudine (D4T)
Group A: Abacavir (ABC)
Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
Children are assigned to remain on their current antiretroviral regimen, which includes D4T. D4T was given at 1 mg/kg twice daily
Children stop taking D4T and switch to ABC. ABC was given at 8 mg/kg twice daily.