Study on Pomalidomide for HIV Control in Patients on ART and During Treatment Interruption

What is this study about?

This clinical trial is focused on studying HIV, a virus that affects the immune system. The study will explore the effects of a medication called Pomalidomide, which is taken in capsule form. The purpose of the study is to understand how Pomalidomide can help control the virus in people living with HIV who are already on antiretroviral therapy (ART), a treatment that helps manage the virus.

Participants in the study will continue their current ART regimen during the first phase of the trial. In the second phase, they will stop taking ART to see how well Pomalidomide helps control the virus on its own. Some participants will receive Pomalidomide, while others will receive placebo capsules. The study will monitor the safety of Pomalidomide and how it affects the virus levels in the body.

The trial will also look at how the immune system responds to the virus during the study. This includes measuring the levels of certain cells in the blood that are important for fighting infections. The study aims to provide more information on whether Pomalidomide can be an effective treatment option for people living with HIV.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including documented HIV-1 infection and a stable antiretroviral therapy (ART) regimen.

Participants must have a CD4+ T cell count above 500 cells/μL and agree to continue ART during the first phase of the study.

2 phase I: treatment with pomalidomide

Participants receive pomalidomide in capsule form, taken orally. The dosage and frequency are determined by the study protocol.

The primary goal is to assess the safety of pomalidomide and its impact on the immune system while continuing ART.

3 phase II: analytical treatment interruption

Participants discontinue ART to evaluate the effect of pomalidomide on controlling HIV without medication.

Regular monitoring of HIV-1 RNA levels and CD4+ T cell counts is conducted to determine when ART should be restarted.

4 monitoring and assessments

Throughout the trial, participants undergo regular health assessments to monitor for any adverse effects and to measure the efficacy of the treatment.

Blood tests are performed to evaluate viral load, immune response, and other health indicators.

5 completion of the study

The study concludes with a final assessment of the participant’s health and the overall impact of pomalidomide on HIV control.

Participants receive guidance on resuming ART if necessary and are provided with a summary of their participation.

Who Can Join the Study?

Must have a documented HIV-1 infection. This means there should be medical records confirming the presence of the HIV-1 virus.
Must have been receiving combination ART (antiretroviral therapy) for at least 1 year and on the same ART regimen for at least 4 weeks before the screening visit. ART is a treatment for HIV.
Must have HIV-1 plasma RNA levels of less than 50 copies/mL for more than 1 year. This should be documented on at least two occasions within the year, and less than 20 copies/mL at screening. A single episode of 50-500 copies/mL is allowed if the next test shows less than 50 copies/mL.
Must have a CD4+ T cell count greater than 500 cells/μL at screening and at least two counts greater than 350 cells/μL in the 24 months before screening. CD4+ T cells are a type of white blood cell important for the immune system.
Must be able and willing to provide informed consent. This means understanding the study and agreeing to participate. Participants must also agree to continue ART during the first phase of the study and stop ART at the start of the second phase.
All participants must agree to avoid conception. This means following strict guidelines to prevent pregnancy in female participants and prevent male participants from causing pregnancy.

Who Cannot Join the Study?

Individuals who do not have HIV-1 infection cannot participate. HIV-1 infection is a type of virus that affects the immune system.
Participants must be within a specific age range, which is not specified here.
Both males and females are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population are not excluded, meaning they can participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark
Ffpgooqal Frh Dk Lplqt Cdwinv Er Sski Lwr Ehxnckdcimmz Iyleqkqujls Y Lm Phrqnwouf Dq Lq Ssjpy Y Li C	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2024
Spain	Not yet recruiting	01.09.2024

Trial locations

Investigated drugs:

Pomalidomide

Pomalidomide is being studied as an immune-enhancing agent for people living with HIV. The trial aims to see how this medication can help control the virus when patients temporarily stop their regular HIV treatment. Pomalidomide is thought to boost the immune system, which might help the body keep the virus in check without the need for continuous antiretroviral therapy (ART).

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4+ T cells. As the virus replicates, it gradually weakens the immune system, making the body more susceptible to infections and certain diseases. The progression of the infection can vary, with some individuals experiencing rapid decline in immune function, while others may remain asymptomatic for years. Over time, if untreated, the infection can lead to acquired immunodeficiency syndrome (AIDS), characterized by a severely compromised immune system. The virus is primarily transmitted through unprotected sexual contact, sharing needles, or from mother to child during childbirth or breastfeeding. Regular monitoring of viral load and CD4+ T cell count is crucial in managing the infection.

Trial ID:

2024-512797-10-00

Protocol code:

PEACH-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Pomalidomide for HIV Control in Patients on ART and During Treatment Interruption

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?