Developing new agents to activate hidden HIV cells
Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein
This study is testing new treatments that aim to wake up hidden HIV cells in people on antiretroviral therapy to see if it helps the immune system get rid of the virus for good.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06441123 on ClinicalTrials.gov |
What this trial studies
This study focuses on the development of new latency-reversing agents (LRAs) that specifically target the Tat viral protein to activate dormant HIV cells in individuals on antiretroviral therapy (ART). By waking up these hidden cells, the goal is to enable the immune system to eliminate the virus, contributing to a potential cure for HIV. The study involves collecting blood samples from HIV-positive individuals with a history of low CD4 counts and undetectable viral loads, followed by laboratory analysis of immune cells treated with the new LRAs. The effectiveness of these agents will be measured through viral RNA and protein detection methods.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals aged 18 or older, on ART, with an undetectable viral load for over 12 months and a history of very low CD4 counts.
Not a fit: Patients who are not on antiretroviral treatment or have a history of cancer within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a breakthrough in HIV treatment by potentially eliminating hidden reservoirs of the virus.
How similar studies have performed: Other studies have shown promise with similar approaches targeting HIV latency, but this specific targeting of the Tat protein is a novel strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 years or older * HIV-positive * On ART (antiretroviral therapy) * HIV-1 RNA undetectable for more than 12 months * Nadir CD4 count \< 200/µL Exclusion Criteria: * Lack of antiretroviral treatment * Immunosuppressive treatments * History of cancer less than 5 years old * Pregnant or breast-feeding women * Persons protected by law (under guardianship or curators), persons under court protection * Participating in another research project with an ongoing exclusion period * Refusal to participate in research * Subject not affiliated to a social security scheme, or not benefiting from such a scheme.
Where this trial is running
Montpellier
- CHU de MONTPELLIER — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Alain MAKINSON, Pr
- Email: a-makinson@chu-montpellier.fr
- Phone: 04 67 33 83 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.