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NCT Number: NCT06441123

Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein

Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. These cells are a major challenge in finding a cure for HIV.

One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (LRAs). This process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase).

Investigators are developing new LRAs that target and activate a viral protein called Tat, which is necessary for the virus to start producing again and for reversing its dormant state.The lead compound, named D10, is the first of its kind to target the Tat protein. This compound has been patented and has shown activity in activating the virus in lab-grown cells. Now, investigators need to test its effectiveness on real target cells from people living with HIV.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with HIV who are on ART. The inclusion criteria for this study are: being HIV-positive, having an undetectable viral load for more than 12 months, and having a history of very low T-CD4 counts (nadir < 200 cells/mm³).

In the lab, investigators will isolate immune cells (PBMCs) from the blood using a special technique. These cells will then be placed in small wells and treated with LRAs for 18-20 hours. Investigators will measure the virus produced in the cell supernatant using two methods: q-RT-PCR for viral RNA and p24 ELISA for viral protein. The results will be analyzed using conventional statistical methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

20 ml of blood (5 tubes of 4 ml) will be collected once.

Primary outcomes

  1. Quantity of p24 in the cell supernatant 18-20 hours after the addition of the LRAs (Latency Reversing Agents)

    Time frame: INCLUSION VISIT

    Viral production is considered significant if the signal obtained from the p24 ELISA of these supernatants is more than twice the background observed in the absence of LRA

Secondary outcomes

  1. Quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs.

    Time frame: INCLUSION VISIT

    quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs.

  2. Measure the effective dose of D10 to reverse the latency of latent HIV-infected PBMCs

    Time frame: INCLUSION VISIT

    effective dose of D10 to reverse the latency of latent HIV-infected PBMCs

Study contacts

Contact information is provided by the study sponsor or research team.

Alain MAKINSON, Pr

CONTACT

[email protected]

04 67 33 83 40

Bruno BEAUMELLE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Université Montpellier

Registry information

Acronym: TatLat

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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