Antiretroviral research for Watoto

Conditions

Human immunodeficiency virus Infections and Infestations Human immunodeficiency virus

Fisayo T, Evans C, Mutasa K, Alber D, Spyer MJ, Rukobo S, Bwakura-Dangarembizi M, Musiime V, Nathoo KJ, Kekitiinwa A, Kityo C, Gibb DM, Klein N, Walker AS, Prendergast AJ.

2026-06-09

10.1093/cid/ciag354

The impact of viraemia on inflammatory biomarkers and CD4+ cell subpopulations in HIV-infected children in sub-Saharan Africa

Andrew J. Prendergast, Alexander J. Szubert, Godfrey Pimundu, Chipo Berejena, Pietro Pala et al. (18 authors)

AIDS2021-04-1411 citations

10.1097/qad.0000000000002916

Virological response and resistance among HIV-infected children receiving long-term antiretroviral therapy without virological monitoring in Uganda and Zimbabwe: Observational analyses within the randomised ARROW trial

Alexander J. Szubert, Andrew J. Prendergast, Moira Spyer, Victor Musiime, Philippa Musoke et al. (16 authors)

PLoS Medicine2017-11-1432 citations

10.1371/journal.pmed.1002432

Once vs twice-daily abacavir and lamivudine in African children.

Musiime V, Kasirye P, Naidoo-James B, Nahirya-Ntege P, Mhute T, Cook A, Mugarura L, Munjoma M, Thoofer NK, Ndashimye E, Nankya I, Spyer MJ, Thomason MJ, Snowden W, Gibb DM, Walker AS, ARROW Trial Team.

2016-07-0112 citations

10.1097/qad.0000000000001116

A Randomized Trial of Prolonged Co-trimoxazole in HIV-Infected Children in Africa

Mutsa Bwakura‐Dangarembizi, Lindsay Kendall, Sabrina Bakeera–Kitaka, Patricia Nahirya-Ntege, Rosette Keishanyu et al. (16 authors)

New England Journal of Medicine2014-01-01110 citations

10.1056/nejmoa1214901

Routine versus clinically driven laboratory monitoring and first-line antiretroviral therapy strategies in African children with HIV (ARROW): a 5-year open-label randomised factorial trial.

ARROW Trial team.

2013-03-0794 citations

10.1016/s0140-6736(12)62198-9

Interventions

First randomisation is to CDM or LCM (1200 children). Second randomisation is to either continuous or induction-maintenance ART strategies for first-line therapy. Children will be randomised immediate

Eligibility

Sex/Gender

All

Age

6 Months to 17 Years

Inclusion criteria

Inclusion criteria: 1. Children should have an adult carer in the household who is either: 1.1. Participating in the DART trial (ISRCTN13968779) or 1.2. Being treated with ART or 1.3. HIV positive but not yet needing treatment but with access to a treatment program when ART is required or 1.4. HIV negative 2. Parents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to clinically driven monitoring (CDM) or laboratory and clinical monitoring (LCM) and to first-line ART strategy 3. Participants must have a confirmed and documented diagnosis of HIV-1 infection 4. At entry participants should be aged: 4.1. 6 Months to 17 years among children and adolescents from DART households 4.2. 6 Months to 12 years among children in non-DART households 5. Participants must be ART naive (except for exposure to perinatal ART for the prevention of mother-to-child HIV transmission) 6. Participants must meet the criteria for requiring ART according to World Health Organization (WHO) stage and CD4 count or CD4 cell percent

Exclusion criteria

Exclusion criteria: 1. Cannot, or unlikely to attend regularly 2. Likelihood of poor adherence 3. Presence of acute infection 4. In receipt of medication contraindicated by ART or on chemotherapy for malignancy 5. Laboratory abnormalities, which are a contraindication for the patient to start ART 6. Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. Monitoring practice (n = 1200): 1.1. Efficacy: progression to a new WHO stage 4 or death 1.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only 2. ART strategies for first-line therapy (n=1200): 2.1. Efficacy: progression to a new WHO stage 4 or death and change in CD4 percentage at 72 and 144 weeks 2.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only	—

Measure

Time frame

1. Monitoring practice (n = 1200): 1.1. Efficacy: progression to a new WHO stage 4 or death 1.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only 2. ART strategies for first-line therapy (n=1200): 2.1. Efficacy: progression to a new WHO stage 4 or death and change in CD4 percentage at 72 and 144 weeks 2.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

England, Uganda, United Kingdom, Zimbabwe

Outcome results

None listed