NCT06640192 Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
| NCT ID | NCT06640192 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2025-05-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Santiago Moreno Guillen
PRINCIPAL INVESTIGATOR
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
Frequently Asked Questions
Who can join the NCT06640192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06640192 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06640192 currently recruiting?
Yes, NCT06640192 is actively recruiting participants. Contact the research team at smguillen@salud.madrid.org for enrollment information.
Where is the NCT06640192 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain.
Who is sponsoring the NCT06640192 clinical trial?
NCT06640192 is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. The principal investigator is Santiago Moreno Guillen at IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.. The trial plans to enroll 24 participants.
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