Ongoing Research

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.