High doses of antiretroviral drugs to eliminate HIV-1 reservoirs

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.

This study is testing whether giving higher doses of HIV medications can help reduce hidden HIV in the body and improve health for people living with the virus.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Academic / other)
• Locations: 2 sites (Madrid, Madrid and 1 other locations)
• Trial ID: NCT06640192 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate the effects of administering high doses of antiretroviral drugs on the latent HIV-1 reservoir in patients. The study will focus on the penetration of these drugs into lymphatic tissues, which is believed to be lower than in plasma, and how this affects persistent viral replication. By using a standardized triple antiretroviral therapy at higher doses, the trial seeks to determine if this approach can significantly reduce the size of the viral reservoir and improve overall health outcomes for HIV patients. The findings could lead to new treatment strategies that enhance the functional cure of HIV.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-positive individuals aged 18 to 60 who have maintained an undetectable viral load for at least 12 months and are on a triple antiretroviral regimen.

Not a fit: Patients with a history of virologic failure, gastrointestinal diseases, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a significant reduction or elimination of the HIV reservoir, improving treatment outcomes and overall health for patients living with HIV.

How similar studies have performed: Previous studies have shown promising results with higher doses of antiretrovirals, indicating potential for success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Madrid, Madrid and 1 other locations

• Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (Not_yet_recruiting)
• Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Santiago Moreno Guillen — IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
• Study coordinator: Santiago Moreno Guillen, PhD

Conditions HIV-1-infection