A5332
Funder: NIH/DAIDS Sponsor: AIDS Clinical Trials Group
Start Date: Screening started December 2017. Enrollment closed March 2019
End Date: Projected stop date is March 2027.
Summary
Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE.
Update
181 participants enrolled. Three prematurely discontinued. 178 are currently in follow-up
A5349
Funder: NIH/DAIDS Sponsor: AIDS Clinical Trials Group
Start Date: Screening started April 2018. Enrollment closed October 2018
End Date: Study stop date was July 2020
Summary
Rifapentine-Containing Treatment Shortening Regimens for Pulmonary Tuberculosis
Update
Closed
A5300B
Funder: NIH/DAIDS Sponsor: AIDS Clinical Trials Group
Start Date: Screening started January 2020. Enrollment on pause.
End Date: Projected stop date is March 2025.
Summary
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)
Update
11 Index cases and 18 Household contacts are enrolled to date. Screening and enrollment are ongoing.
A5381
Funder: NIH/DAIDS Sponsor: AIDS Clinical Trials Group
Start Date: Screening started November 2019. Enrollment is ongoing
End Date: Projected stop date is May 2024.
Summary
Assessing Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First or Second-Line ART
Update
140 participants enrolled and on follow-up. Screening and enrollment are ongoing.
A5360 (MINMON)
Funder: Funder: NIH/DAIDS Sponsor: AIDS Clinical Trials Group
Start Date: Screening started June 2019. Enrollment closed July 2019
End Date: Projected stop date was February 2021.
Summary
A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations who are HCV Treatment Naïve with
Evidence of Active HCV Infection (MINMON)
Update
Closed
VirTUAL WP5
Funder: EDCTP and the European Union Sponsor: University of Liverpool
Start Date: Projected end date is November 2022
End Date: Participant follow up ended in September 2020
Summary
Investigation of the PK of boosted protease inhibitors and rifamycins in pregnant women, children and adolescents.an observational pharmacokinetic study nested within the virtual consortium.
Update
Study activities were completed, awaiting sample shipment.
DERIVE (Dose escalation study)
Funder: EDCTP and the European Union Sponsor: University of Liverpool
Start Date: Started November 2020,
End Date: Participant follow up is projected to end in June 2022
Summary
A phase 3, open-label, dose escalation study to determine the pharmacokinetics of atazanavir administered with rifampicin to HIV positive adults on secondline art regimen with suppressed hiv-1 VL.
Update
Recruiting is ongoing, though it had been paused. The DSMB sat and gave permission to continue.
(START) Strategic Timing of AntiRetroviral Treatment.
Funder: NIH Sponsor: University of Minnesota through MRC CTU as Coordinator
Start Date: Started 2012,
End Date: Was projected to end in December 2021
Summary
Assessing how early ART strategy might affect other aspects of care, such as chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.
Update
143 participants are being followed up to the end of this year
NADIA
Funder: Funding: ViiVHealth care Sponsor: Infectious Disease Institute (IDI)
Start Date: Last participant will be seen in December 2021
End Date:
Summary
Nucleosides And Darunavir/ Dolutegravir In Africa. A randomized controlled trial of darunavir versus dolutegravir and tenofovir versus zidovidine in second-line antiretroviral therapy regimens for the public health approach in sub-Saharan Africa.
Update
With the new amended protocol, participants with nondetectable viral load were to be exited by October. (after completion of their week 96visit) But those with viral load above 1000cps/ml were given extra 12week undergoing intensive adherence counseling. After doing a repeat VL, a decision will be made following the national guideline and then be exited from the study. They are 6 in number and hope to be exited in December 2021.
TRUNCATE TB
Funder: National University Hospital (Singapore)
Start Date: Started in December 2019, will end when participants have reached the last visit and when data has been cleaned
End Date: Last visit will be in March 2022
Summary
The study tests the hypothesis that the TRUNCATE-TB management strategy is noninferior to the standard TB management strategy assessed by the proportion of patients with unsatisfactory outcome at 2 years (96 weeks)
Update
At week 48, remaining with four study visits.
ROSETTA
Funder: National University Hospital (Singapore)
Start Date: Started in September 2020
End Date: Last participant followup visit was in June 2021. Study closure expected in December 2021.
Summary
ROSuvastatin Evaluation as a Tuberculosis Treatment Adjunct
Update
Participants’ followup ended in June but still doing data cleaning and analysis. Hope to close in December 2021.
K23 Pericardial fat, inflammation, and Structural heart disease in chronic HIV infection
Funder: NIH Sponsor: CWRU
Start Date: Participants have been informed that they will be called back after the amendment has been approved.
End Date:
Summary
The study is attempting to evaluate the sensitivity of a variety of biomarkers to detect early structural changes in left ventricular systolic and diastolic performance before symptoms develop
Update
The study is not active at the moment as they wait for more funding and amendment of the protocol. Hope to start second phase by December 2021.(As of Sep. 2021).
Rheumatic Heart Disease (RHD) study
Funder: NIH Sponsor: CWRU
Start Date: Started in 2013.No specified end date.
End Date:
Summary
The study is investigating the role of HIV and auto-antibodies among patients with rheumatic heart disease in Uganda:
Update
Project is still running although not funded by the sponsor. Participants are being followed up in the clinic.
RARA (Rapid AirJump and RNA Amplification)
Funder: Government of Uganda through PRESIDE and MOSTI Sponsor: JCRC
Start Date: Samples for field validation are currently being collected and the target is 3 samples from each of the 80 confirmed COVID19 cases and 2433 one-time samples from confirmed negative cases.
End Date:
Summary
Development and validation of Simple and Cost Effective PCR Assays for SARS-CoV-2 Diagnostics.
Update
Not yet analysed the paired samples of saliva and NP collected however the project received the equipment for analysing the samples using RARA version 2.(As of Sep. 2021).
Next Generation Sequencing Assay for COVID Mass screening
Funder: Government of Uganda through PRESIDE and MOSTI Sponsor: JCRC
Start Date: Samples for field validation are currently being collected and the target is 3 samples from each of the 80 confirmed COVID19 cases and 2433 one-time samples from confirmed negative cases.
End Date:
Summary
Development of Assays for mass screening of SARS Cov2 infections in communities
Update
Projected was put on hold due to delayed funding.
Antigen ELISA Based Assay
Funder: Government of Uganda through PRESIDE and MOSTI Sponsor: JCRC
Start Date:
Started in September 2021.Projected end date is June 2023
End Date:
Summary
Validation of an antigen ELISA based assay for the detection of SARS COV2 RNA
Update
Project waiting for funding.
Long Acting ARTCARES Study
Funder: Janssen Sponsor; JCRC
Start Date: Started in September 2021.Projected end date is June 2023.
.
End Date:
Summary
Cabotegravir and Rilpivirine: Efficacy and Safety Study (CARES). Assessing the use of long acting injectable ART in sub-Saharan Africa.
Participant recruitment started. 9 participants enrolled. Note: screen failure is high due to anti HB core antibody (12 out of 14 SOs). Oct 2021.
ACTIV3/TICO
Funder: NIH Sponsor: CWRU
Start Date: Samples for field validation are currently being collected and the target is 3 samples from each of the 80 confirmed COVID19 cases and 2433 one-time samples from confirmed negative cases.
End Date:
Summary
Master protocol accessing therapeutics in COVID-19 in hospitalized patients. (Therapeutics in In-patients with COvid-19 (TICO)
Update
Started Participants recruitment.19 participants were recruited as of October 15.
Protocol 0106
Sponsor: Gilead Sciences
Start Date: Started in 2013,
End Date: Projected to end in January 2022
Summary
It is a Phase 2/3, Open-Label Study to confirm the dose of elvitegravir/cobicistat/emtricitabin e/tenofoviralafenamide (E/C/F/TAF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment naive adolescents and evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of E/C/F/TAF STR in HIV-1 infected, ART naive adolescents and virologically suppressed HIV1 infected children. Antiviral activity is determined by the achievement of HIV-1 RNA < 50 copies/mL at Weeks 24 and 48.
Update
following-up participants until they reach their 360 week visit.
Protocol GS-US-380-1474
Funder: Gilead Sciences
Start Date: Started in 2017
End Date:
Summary
The Pharmacokinetics, Safety, and Antiviral Activity of the (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed Adolescents and Children
Update
Study is still recruiting. Amendment to the study make it hard to estimate exit dates.
PAINT
Funder: TIBOTEC, Johnson and Johnson
Start Date: Started 2009, ongoing. December 2010 Part 1b – April 2012 Part 2 – November 2012. Recruitment closed on 24 August 2021
End Date: End date unclear.
Summary
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of TMC278 in Human Immunodeficiency Virus Infected Adolescents.
Update
Currently following up participants
ODYSSEY (PENTA 20), LTFU
Funder: ViiV through PENTA
Start Date: Started November 2016
End Date: Projected to end in in 2023
Summary
Dolutegravir (DTG) based Antiretroviral Therapy Vs Standard of Care (SOC) in Children with HIV infection starting First-line or Switching to Second-line ART
Update
Currently conducting Long term follow-up.
SMILE (PENTA 17)
Funder: PENTA
Start Date: Closed
End Date:
Summary
SMILE: Evaluating the safety and efficacy of (DTG) administered with (DRV/r) compared to current standard ART in HIV-1 infected, virologically suppressed paediatric participants.
Update
Exited all participants sponsors will provide participants will Darunavir to the exited participants till September 2021
MICRONUTRIENT STUDY
Funder: NIH Sponsor: CWRU
Start Date: Closed
End Date:
Summary
The Relationship of metabolic factors, micronutrients and inflammation in HIV exposed and infected, HIV infected and HIV unexposed Uninfected Children in Uganda.
Update
Study ended.
DRIBS STUDY
Funder: EDCTP Sponsor: JCRC
Start Date: Started in May 2018
End Date: May end in 2023 or take longer than that
Summary
Aims to assess the importance of an HIV baseline drug resistance test in HIV positive infants born to HIV positive mothers who were on ART during pregnancy. (Low frequent HIV drug resistant polymorphisms in infants born to HIV sero-positive mothers: Implications on response to therapy)
Update
Has exited about 8 participants. It is also still recruiting. Follow-up of participants is for 2 years.
CHAPAS 4 (LTFU)
Funder: EDCTP Sponsor: MRC-CTU
Start Date: Started January 2019
End Date: Will end in 2022 plus the three year follow-up once approved
Summary
Children with HIV in Africa – Pharmacokinetic and acceptability of simple second line Antiretroviral regimen.
Update
long-term follow-up for 3 years. 16 exited not part of LTFU
K23 (paediatrics)
Funder: NIH Sponsor: University hospital Cleveland medical centre
Start Date: Started in 2018,
End Date:
Summary
Predictors of cardiovascular diseases and inflammation in Ugandan children with HIV
Update
Ended
HESTIA 3
Funder: AstraZeneca
Start Date: This was terminated by the sponsor
End Date:
Summary
A randomized, double-blind, parallel-group, multi-center, phase III study to evaluate the effect of ticagrelor bid versus placebo in reducing the number of VOCs in pediatric patients with sickle cell disease.
Update
This was terminated by the sponsor
LOLLIPOP
Funder: Drugs for Neglected Diseases initiative (DNDi)
Start Date: This was terminated by the sponsor
End Date:
Summary
Phase1/11 open label randomized cross-over pharmacokinetic safety and acceptability study of the abacavir / lamivudine / lopinavir/ ritonavir/ – 30/15/40/10mg (4-in-1) six dose combination vs Lopinavir/r / 40/10mg pallets plus dual; abacavir / lamivudine / 60/30 mg tablets in HIV infected children.
Update
All participants were exited and the study was terminated
The Iron study
Funder: NIH Sponsor: UNiv. of Minnesota – GHU
Start Date: Started in July 2020
End Date: Original end date was in 2022. The study duration is two years however a lot of time has been lost due to COVID, the study team is planning to meet in March to see how they can adjust study duration.
Summary
The role of Iron Deficiency in the Neurodevelopment of Children Perinatally exposed to HIV
Update
Participants attend only one visit, 157 participants have attended their only visit. The study needs to recruit a total of 210 participants expected to be recruited.
HEADS UP
Funder: Royal Holloway University – UK
Start Date: Started in September 2019
End Date: Proposed end date is March 2022
Summary
Study on HIV disclosure among adolescents and young adults born with HIV
Update
Resumed participants recruitment on the 10th September for 2nd phase.
PAINT follow on (TMC2781FD3004)
Funder: Janssen Research and Development
Start Date: Roll over started in March 2021. Going on up to until when Rilp is in the country.
End Date:
Summary
Follow on study / role over from the Original paint study
Update
Received all approvals. Now ongoing.
IMARA study
Funder: IMARA Inc.
Start Date: Projected to end in 2022.
End Date: Projected stop date is March 2027.
Summary
A Phase 2b/3 Study to Evaluate the Safety and Efficacy of IMR687 in Subjects with Sickle Cell Disease.
Primary Objectives • To evaluate the foetal haemoglobin (HbF) response to IMR-687 versus placebo • To evaluate the safety of IMR687 versus placebo.
Update
Started participants recruitment
GUT study (HS 1036ES)
Funder: NIH/ CWRU
Start Date: Projected to end in 2022.
End Date: Projected stop date is March 2027.
Summary
Gut Integrity and Metabolic Complications in Youth Living with HIV in Uganda – A cross sectional study.
Update
Projected to start in March 2021 possible end date Sept 2022.