Study: NCT02028676

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Clinically Driven Monitoring (CDM)
Description: Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Laboratory plus Clinical Monitoring (LCM)
Description: Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Arm A: ABC+3TC+NNRTI
Description: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance
Description: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance
Description: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Once-daily ABC+3TC

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Twice-daily ABC+3TC

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Continued cotrimoxazole prophylaxis

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Stopped cotrimoxazole prophylaxis