EDCTP Portfolio Clinical Trials and Integrated Projects The EDCTP portfolio of funded projects on HIV/AIDS covers drugs, vaccines and microbicides as well as capacity building projects that do not involve testing of investigational products. 1.1 HIV/AIDS treatment clinical trials ........................................................................... - 3 - 1.1.1 CHAPAS-1 ........................................................................................................... - 6 - 1.1.2 CHAPAS-3 .......................................................................................................... - 10 - 1.1.3 MONOD ............................................................................................................. - 15 - 1.1.4 EARNEST ........................................................................................................... - 18 - 1.1.5 2LADY ............................................................................................................... - 22 - 1.1.6 NUSTART ........................................................................................................... - 25 - 1.1.7 PROMPT ............................................................................................................. - 28 - 1.1.8 RAFA ................................................................................................................. - 31 - 1.1.9 REMSTART ......................................................................................................... - 34 - 1.2 HIV/AIDS prevention and treatment clinical trials .................................................... - 36 - 1.2.1 Kesho Bora study ................................................................................................ - 37 - 1.2.2 ComTru Study .................................................................................................... - 42 - 1.2.3 VITA Studies ...................................................................................................... - 46 - 1.2.4 PROMISE-PEP Studies .......................................................................................... - 51 - 1.3 HIV/AIDS microbicides capacity building and clinical trials ........................................ - 55 - 1.3.1 Van de Wijgert .................................................................................................... - 57 - 1.3.2 TVMTU ............................................................................................................... - 61 - 1.3.3 MRC CTU/MDP 301 .............................................................................................. - 66 - 1.3.4 Mandaliya-Biomarkers HIV Mic .............................................................................. - 72 - 1.4 HIV/AIDS vaccines capacity building ...................................................................... - 75 - 1.4.1 SASHA ............................................................................................................... - 77 - 1.4.2 HIVTAB .............................................................................................................. - 81 - 1.4.3 TaMoVac-01 ....................................................................................................... - 85 - 1.4.4 CHIVTUM ........................................................................................................... - 87 - 1.4.5 AfrEVacc ............................................................................................................ - 93 - 1.5 HIV/AIDS vaccines clinical trials .......................................................................... - 102 - 1.5.1 PedVacc ........................................................................................................... - 104 - 1.5.2 TaMoVac-01 ..................................................................................................... - 108 - 1.5.3 TaMoVac II ....................................................................................................... - 113 - 2 Tuberculosis ................................................................................................... - 116 - 2.1 Tuberculosis treatment clinical trials .................................................................... - 116 - 2.1.1 TB SurMark ...................................................................................................... - 118 - 2.1.2 HIV-TB Pharmagene .......................................................................................... - 121 - 2.1.3 PPK.DDK - HIV and TB medications ..................................................................... - 126 - 2.1.4 Rifaquin ........................................................................................................... - 130 - 2.1.5 REMox I and II ................................................................................................. - 132 - 2.1.6 PanACEA-HIGHRIF ............................................................................................ - 137 - 2.1.7 PanACEA-SQ109 ............................................................................................... - 142 - 2.2 Tuberculosis vaccines clinical trials ...................................................................... - 145 - 2.2.1 TB Vac prep Ethiopia/THYB-03 ............................................................................ - 146 - 2.2.2 Van't Hoog-TB Vac prep Kenya ........................................................................... - 149 - 2.2.3 TB Vac prep Uganda .......................................................................................... - 153 - 2.2.4 THYB-04 .......................................................................................................... - 156 - 2.2.5 TB-021 ............................................................................................................ - 160 - 2.2.6 AERAS 402/Crucell Ad35 .................................................................................... - 163 - 2.2.7 Aurum 102/THYB-05 ......................................................................................... - 167 - 2.3 Tuberculosis diagnostics clinical trials .................................................................. - 171 - 2.3.1 TB NEAT .......................................................................................................... - 173 - 2.3.2 TB CHILD ......................................................................................................... - 181 - 2.3.3 AE TBC ............................................................................................................ - 185 - 3 Malaria .......................................................................................................... - 189 - 3.1 Malaria treatment clinical trials ........................................................................... - 189 - 3.1.1 4ABC study ...................................................................................................... - 191 - 3.1.2 SMAC-II and III (Dose Optimisation Study) .......................................................... - 196 - 3.1.3 PREGACT ......................................................................................................... - 201 - 3.1.4 MiPPAD ............................................................................................................ - 208 - 3.1.5 IPTp-SP ........................................................................................................... - 215 - 3.1.6 WANECAM ........................................................................................................ - 223 - 3.1.7 ADAPT ............................................................................................................. - 230 - 3.2 Malaria vaccines clinical trials ............................................................................. - 235 - 3.2.1 GMZ2 .............................................................................................................. - 238 - 3.2.2 MVVC .............................................................................................................. - 241 - - 2 - 1.1 HIV/AIDS treatment clinical trials Project Phase Product(s) Manufacturer / Study population Status Acronym of trial Developer (Coordinator) CHAPAS-1 I/II Pedimune (Triomune Baby/Junior) Cipla PAEDIATRIC Completed (Chintu) tablets: Pharmaceuticals 211 HIV-1 infected children stavudine (d4T), lamivudine (3TC) (≥3 months - ≤14 years) and nevirapine (NVP) in paediatric co-formulated fixed-dose combinations CHAPAS-3 II Baby and Junior Triomune Cipla PAEDIATRIC Ongoing (Mulenga) (d4T+3TC+NVP); Lamivir S Pharmaceuticals Across the full paediatric age-range, in (d4T+3TC); both previously untreated (ART naïve) 3TC (lamivudine) +ABC (abacavir) children and in children with undetectable baby and junior scored tablets viral load who have already been ZDV (zidovudine) +3TC receiving d4T+3TC+NVP as first-line (lamivudine) baby and junior ART. scored tablets ZDV (zidovudine) +3TC 480 children aged 1 month to 13 years (lamivudine) +NVP (nevirapine) have been recruited from three Ugandan scored tablets. and one Zambian paediatric clinical centres and are followed for a minimum of 96 weeks. MONOD III Azidothymidine-Zidovudine (AZT); National PAEDIATRIC Ongoing (Leroy) Zidovudine (ZDV) syrup; programmes HIV-infected children (3 months – 12 Lamivudine (3TC) syrup; months) Nevirapine (NVP) syrup; Abacavir Early diagnosed between age 6 weeks (ABC) syrup ; Efavirenz (EFV) and 24 months of life syrup Initial prospective