RecruitingPhase 2NCT06640192

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

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.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

24 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria11

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 Criteria14

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.

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Interventions

DRUGStandardised 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.

DRUGHigh doses Triple therapy antiretroviral drugs

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