Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
The two original objectives were to determine in HIV-infected children initiating
antiretroviral therapy (ART):
1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of
disease progression or death as routine laboratory and clinical monitoring (LCM) for
toxicity (haematology/biochemistry) and efficacy (CD4)?
2. Whether induction with four drugs from two ART classes followed by maintenance with
three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse
transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical
outcome?
Two secondary objectives were to determine
3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir
after 48 weeks on ART will have a similar outcome in terms of virological suppression
and will result in improvements in adherence to ART?
4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who
have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation
or death as continuing daily cotrimoxazole?
Phase:
Phase 4
Details
Lead Sponsor:
Medical Research Council
Collaborators:
Department for International Development, United Kingdom GlaxoSmithKline ViiV Healthcare
Treatments:
Abacavir Dideoxynucleosides Efavirenz Lamivudine Lamivudine, zidovudine drug combination Nevirapine Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Zidovudine