Not recruiting

Study on Reducing HIV Latent Reservoirs Using High Doses of Lamivudine, Maraviroc, and Dolutegravir Sodium for Patients with HIV Infection

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of HIV infection, a virus that attacks the body's immune system. The study will use high doses of three antiretroviral drugs: Lamivudine, Maraviroc, and Dolutegravir Sodium. These medications are designed to help control the virus in the body. The purpose of the study is to evaluate how these drugs can reduce the hidden amount of the virus in the body, known as the latent reservoir, by reaching effective levels in the tissues.

Participants in the study will receive these medications in the form of film-coated tablets, which are taken orally. The study will be conducted over a period of up to 24 months. During this time, researchers will monitor the participants to see how the size of the latent reservoir of the virus changes. This will involve measuring the total and intact proviral DNA, which is a way to assess the amount of virus that remains hidden in the body.

The trial is open-label, meaning both the researchers and participants will know which medications are being administered. It is a randomized and controlled study, which helps ensure that the results are reliable. The study aims to provide valuable insights into how high doses of these antiretroviral drugs can potentially eliminate the hidden virus in people living with HIV.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have an undetectable plasma viral load, which means less than 50 copies of HIV RNA in blood plasma for at least 12 months prior to inclusion.
The patient should already be on antiretroviral treatment with a triple regimen that includes an integrase inhibitor and have R5 viral tropism, determined in proviral DNA.
Step 2
Medication administration
The patient will receive high doses of antiretroviral drugs to evaluate the variation in the size of the latent cellular reservoir of HIV-1.
The medications include Lamivudine (300 mg), Maraviroc (300 mg), and Dolutegravir sodium (50 mg).
All medications are administered orally in the form of film-coated tablets.
Step 3
Monitoring and evaluation
The primary endpoint of the study is to measure the size of the latent cell reservoir by assessing total and intact proviral DNA (IPDA).
Regular monitoring will be conducted to evaluate the effectiveness of the treatment in reducing the latent reservoir of HIV-1.
Step 4
Completion of the study
The estimated end date for the study is September 16, 2027.
The study aims to provide insights into the potential of high-dose antiretroviral therapy in eliminating the latent reservoir of HIV-1.

Who can join the trial?

7 criteria

The patient must have an HIV infection.
The patient must have an undetectable plasma viral load, which means less than 50 copies of HIV RNA in blood plasma, for at least 12 months before joining the study.
The patient must be on antiretroviral treatment with a combination of three drugs, including a type of drug called an integrase inhibitor, which helps control HIV.
The patient must have R5 viral tropism, which is a specific type of HIV, determined in their proviral DNA (the genetic material of the virus).
The patient must be between the ages of 18 and 65 years old.
Both female and male patients can participate.
The patient should not be part of a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who cannot join the trial?

4 criteria

Individuals who do not have an HIV infection cannot participate. HIV infection is a condition caused by the human immunodeficiency virus, which attacks the body's immune system.
Participants must be within a specific age range, which is not specified here, but if you are outside this range, you cannot participate.
Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

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Verified sites

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Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

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Investigated drugs

Antiretroviral Drugs are medications used to treat HIV. In this clinical trial, high doses of these drugs are administered to help reduce the hidden, inactive form of the virus in the body. The goal is to see if these increased doses can effectively decrease the amount of the virus that remains dormant in the cells, which is a significant challenge in treating HIV.

What is already known about the treatment

Antiretroviral Drugs – These medications are administered orally and are used to treat HIV infection. They are currently well-established in medical practice and literature as a primary treatment for managing HIV. The main therapeutic indication is to reduce the viral load in patients with HIV, thereby improving immune function and preventing the progression to AIDS. At the molecular level, antiretroviral drugs work by inhibiting the replication of the HIV virus, targeting specific enzymes or proteins necessary for the virus to multiply. They are classified pharmacologically as antiretroviral agents, which include various classes such as protease inhibitors, reverse transcriptase inhibitors, and integrase inhibitors.

Investigated diseases

HIV Infection – HIV infection is caused by the human immunodeficiency virus, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without treatment, HIV can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, and it can remain asymptomatic for years.