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RECRUITING

NCT06640192

PHASE2

Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir

Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

View on ClinicalTrials.gov

Summary

The HIV epidemic represents one of the greatest health challenges worldwide, with important social and economic implications for public health. Although combination antiretroviral therapy (TAR) is effective in controlling infection and delaying disease onset, as well as improving the quality of life of infected persons, the relevant medical needs caused by HIV-1 infection are not yet fully met by TAR. The main obstacle to curing HIV is the establishment and maintenance of the viral reservoir. Therefore, we believe that this clinical trial will provide knowledge, for the first time, of the increase of antiretroviral drug levels in lymphatic tissue achieved by simultaneous administration of antiretroviral drugs at higher than usual doses, and their effect on persistent viral replication in intestinal lymphatic tissue and, as a consequence, on the latent cellular reservoir of HIV.

Official title: Clinical Trial Phase II, Multicenter, Open-label, Randomized and Controlled Trial to Eliminate the Latent Reservoir of HIV-1 by Administering High Doses of Antiretroviral Drugs.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-30

Completion Date

2027-01

Last Updated

2025-06-25

Healthy Volunteers

Conditions

HIV-1-infection

Interventions

DRUG

Standardised triple antiretroviral therapy

patients have to use Triple therapy antiretroviral drugs on their usual regimen containing an integrase inhibitor. There are many types of drugs within this group, so they are not specified.

DRUG

High doses Triple therapy antiretroviral drugs

dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h

Inclusion Criteria: * Patients who, after receiving information about the study design, the aims of the study, the possible risks that may arise from it and the fact that they can refuse to collaborate at any time, give written consent to participate in the study. * Be over 18 years of age and under 60 years of age. * Understand the purpose of the study and be available to perform the visits and procedures established in the protocol. * Persons with HIV being followed up in HIV consultations. * Antiretroviral treatment with a triple regimen containing an integrase inhibitor. * Undetectable plasma viral load (\<50 copies of HIV RNA in blood plasma) for at least 12 months prior to inclusion. * No history of prior virologic failure. * No known gastrointestinal disease. * R5 viral tropism, determined on proviral DNA. * In women: negative urine pregnancy test performed within 7 days prior to the start of study treatment in women of childbearing age and if \< 2 years post menopause. * Women of childbearing age and male partners of childbearing age must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives, or hormonal contraceptive implants) and to continue using them until 6 months after the last dose of treatment. Exclusion Criteria: * Chronic Hepatitis B (HBsAg +) * Untreated chronic hepatitis C * Viral tropism X4 * Pregnancy or planning to become pregnant during the course of the study. * Lactation. * Abnormal coagulation parameters (PT\> or equal to 1.2 LSN). * Thrombocytopenia (platelet count \<50000). * Transaminases in values greater than 3 times normal. * Impaired renal function (plasma creatinine \>1.5 mg/dl, creatinine clearance \<60 ml/min/1.73 m2). * Contraindications for the performance of any of the study procedures (colonoscopy/bowel biopsy) or conscious sedation. * Anemia (greater than or equal to grade 1). * Administration of aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited 1 week before endoscopy. * Concomitant treatment with cytochrome CYP3A inducers or inhibitors. * Patients in whom there is a contraindication for use according to the established in the technical data sheet or known hypersensitivity to the drugs under investigation or who, according to the investigator's criteria, it is not advisable to participate.

Locations (2)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain