Identification of novel agents for HIV cure or remission
| ISRCTN | ISRCTN14372332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14372332 |
| Secondary identifying numbers | TMA2017SF-1955 |
- Submission date
- 08/09/2021
- Registration date
- 14/09/2021
- Last edited
- 28/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
HIV continues to be a major public health problem in Africa. Although taking HIV medications has reduced HIV-associated deaths and improved lifespan, it does cure people of the infection. Patients must take medications daily for the rest of their lives and this comes with side effects, high costs, and the virus becoming resistant to some of the medication.
It is difficult to cure HIV because after infection some of the virus hides in cells that are not dividing and sleeps there until the HIV medicine is discontinued then they come out and make the person sick. One way to try and cure HIV is therefore to find compounds that can wake the virus up from sleep so that the HIV medicine can work to clear them and destroy the cells that contain them. In this study, we propose to screen several compounds for their ability to wake the sleeping virus up, select the most effective and test them in non-dividing cells taken from HIV patients whose viruses are undetectable.
Who can participate?
Adults (18 years and above) living in Ghana who are HIV infected and on HIV medication. These persons must be attending clinic at the three study sites: Korle-Bu Teaching Hospital, Korle-Bu, Accra, University of Ghana Hospital, Legon, Accra and LEKMA Hospital, Teshie, Accra. The persons must willingly decide to be part of the study and must give a written, signed consent.
What does the study involve?
Each eligible person will be asked to answer questions concerning their knowledge about efforts being made to cure HIV. Every three months when they come to clinic, they will be asked about how they are doing, whether they are taking their HIV medications and whether they have any problems with the medications. Then one tube of blood (about 10 mls) will be collected from them to be used to measure how much of the virus is in the blood and their white cell (CD4) counts. On some visits, their urine samples will be collected. The whole process during each visit will take about 20 minutes. We intend to follow them up for two years during this study. We will select those who have undetectable virus to partake in the studies to wake the sleeping virus up. This study will help better understand HIV in order to figure out whether it can be better treated or eventually even be cured.
What are the possible benefits and risks of participating?
Benefits: The CD4 count and viral load will be measured every 3 months. The participant’s doctor will be informed if the viral load is going up or not coming down as expected even though the participant is taken their medications. Your doctor may change your medications at that point. This could be a potential benefit from the study
Potential Risks: Participants may experience discomfort, bruising, and/or bleeding at the site of needle insertion. This will be monitored for about 5 minutes after the blood is taken to make sure you the participant is fine before leaving the clinic. Occasionally, some people experience dizziness or feel faint. The investigator is willing to discuss your concerns about any of these risks.
Where is the study run from?
Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra (Ghana)
When is the study starting and how long is it expected to run for?
March 2018 to April 2025
Who is funding the study?
The study is funded by the European and Developing Countries Clinical Trials Partnership. This project is part of the EDCTP2 programme support by the European Union.
Who is the main contact?
Dr. George Boateng Kyei, gkyei@noguchi.ug.edu.gh
Contact information
Scientific
Virology Department
University of Ghana Noguchi Memorial Institute for Medical Research
Legon
Accra
LG 581
Ghana
 ORCID ID |
0000-0002-8678-4656 |
|---|---|
| Phone | +233 551989937 |
| gkyei@noguchi.ug.edu.gh |
Public
Virology Department
University of Ghana Noguchi Memorial Institute for Medical Research
Legon
Accra
LG 581
Ghana
| ORCID ID |
0000-0002-6634-8742 |
|---|---|
| Phone | +233 24478567 |
| ebonney@noguchi.ug.edu.gh |
Study information
| Study design | Multicenter longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Identification of novel HIV reactivation agents: towards building translational HIV Cure Research Infrastructure in Ghana |
| Study acronym | H-CRIS |
| Study objectives | Epigenetic modifying compounds will be more effective reactivation agents |
| Ethics approval(s) | Approved 05/09/2018, Noguchi Memorial Institute for Medical Research Institutional Review Board (Accra, Ghana, +233 302916438; nirb@noguchi.ug.edu.gh), ref: CPN 002/18-19; renewed 04/04/2025 |
| Health condition(s) or problem(s) studied | identification of epigenetic modifying compounds and assessing their effectiveness in reactivating HIV from latency |
| Intervention | An epigenetic library of compounds will be screened in vitro for their ability to reactivate HIV from latency. The most effective will be selected and evaluated in resting T cells isolated from HIV patients on combination antiretroviral therapy and virally suppressed. The in vitro assessment of compounds will be accomplished in the first phase while the patients are followed up and their viral loads measured every 3 months for 2 years. Then the virally suppressed patients (viral load < 50copies/ml) will be selected and their blood samples collected for the ex-vivo assay for reactivation studies. |
| Intervention type | Other |
| Primary outcome measure | Reactivation capacity of the compounds in patient resting T cells will be measured using the quantitative RT PCR method at 48 hours of incubation ex-vivo |
| Secondary outcome measures | Virologic suppression will be measured using viral load measurements with real time PCR every 3 months for 2 years |
| Overall study start date | 01/03/2018 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 390 |
| Key inclusion criteria | 1. HIV infected 2. Adults 18 years and above 3. On combination antiretroviral therapy 4. Provided informed consent |
| Key exclusion criteria | Not providing informed consent |
| Date of first enrolment | 21/08/2019 |
| Date of final enrolment | 06/02/2020 |
Locations
Countries of recruitment
- Ghana
Study participating centres
Accra
-
Ghana
Accra
-
Ghana
Teshie
Accra
-
Ghana
Sponsor information
Research organisation
Off Akilagpa Sawyerr Road
University of Ghana Campus
Legon
Accra
BOX LG 581
Ghana
| Phone | +233 302 501179 |
|---|---|
| info@noguchi.ug.edu.gh | |
| Website | http://www.noguchimedres.org/ |
"ROR" |
https://ror.org/00f1qr933 |
Funders
Funder type
Government
Private sector organisation / International organizations
- Alternative name(s)
- Le partenariat Europe-Pays en développement pour les essais cliniques, A Parceria entre a Europa e os Países em Desenvolvimento para a Realização de Ensaios Clínicos, The European & Developing Countries Clinical Trials Partnership, European and Developing Countries Clinical Trials, EDCTP
- Location
- Netherlands
Results and Publications
| Intention to publish date | 30/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Current publication and dissemination plan as of 19/05/2025: Viral load data have been shared with clinicians to guide patient management Planned publication in a high-impact peer-reviewed journal 8 peer-reviewed articles have been published Two papers are in draft and will be submitted by 31/07/2025 Policy brief to stakeholders will be submitted by 30/06/2025 Previous publication and dissemination plan as of 16/05/2025: Viral load data will be shared with clinicians to guide patient management. Planned publication in a high-impact peer-reviewed journal. 8 peer-reviewed articles have been published Policy brief to stakeholders. Previous publication and dissemination plan: Planned publication in a high impact peer-reviewed journal. Policy briefs to stakeholders. Viral load data will be shared with clinicians to guide patient management. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/09/2021 | No | No | ||
| Other publications | Healthcare provider interview study | 11/06/2024 | Yes | No | |
| Other publications | Patient questionnaire study | 01/01/2021 | 11/06/2024 | Yes | No |
| Results article | 01/01/2021 | 28/05/2025 | Yes | No | |
| Results article | 31/05/2023 | 28/05/2025 | Yes | No | |
| Results article | 19/03/2025 | 28/05/2025 | Yes | No |
Additional files
Editorial Notes
28/05/2025: Publication references added.
19/05/2025: Publication and dissemination plan updated.
16/05/2025: The following changes were made to the trial record:
1. The study website was changed from https://noguchimedres.org/index.php/h-cris to https://noguchi.ug.edu.gh/research-activities/hiv-cure-research-infrastructure-study-group-h-cris/
2. The participant level data sharing statement was changed.
17/01/2025: The participant level data sharing statement was added
11/06/2024: The following changes were made to the study record:
1. The overall study end date was changed from 30/04/2023 to 30/04/2025.
2. The intention to publish date was changed from 30/04/2024 to 30/04/2026.
3. Publication references added.
13/09/2021: Trial's existence confirmed by Noguchi Memorial Institute for Medical Research Institutional Review Board.
