Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.

Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir.

If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).

The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.

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Key information

Conditions

HIV-1 Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections 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

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
Aged over 18 years.
Chronic HIV infection
Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA/mL) for at least 2 years.
CD4+ T lymphocyte count above 350 cells/mm3.
Understand the objective of the study and be available to make frequent visits to the hospital.

Exclusion criteria

Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
Proven resistance against the antiretroviral drugs under study.
Planned interruption of antiretroviral therapy.
Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
Taking a fusion inhibitor (enfuvirtide).
Pregnancy or intention to become pregnant during the study.

Treatment and study plan

raltegravir

Drug

Raltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp & Dohme. A dose of 400 mg will be administered every 12 hours

Primary outcomes

To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

Pilot Study Of The Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Dec 12, 2008
Registry last updated: Feb 1, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed