Actively Recruiting
Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-06-25
24
Participants Needed
2
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who give written consent after receiving study information
- Age over 18 years and under 60 years
- Understand the study purpose and are available for visits and procedures
- Diagnosed with HIV and followed in HIV care
- On triple antiretroviral therapy including an integrase inhibitor
- Undetectable viral load (<50 copies/mL) for at least 12 months before inclusion
- No history of prior virologic failure
- No known gastrointestinal disease
- R5 viral tropism confirmed on proviral DNA
- Women of childbearing age must have a negative pregnancy test within 7 days before treatment start
- Women of childbearing age and their male partners must agree to use effective contraception until 6 months after last treatment dose
You will not qualify if you...
- Chronic Hepatitis B infection (HBsAg positive)
- Untreated chronic Hepatitis C
- Viral tropism X4
- Pregnancy or planning pregnancy during study
- Breastfeeding
- Abnormal coagulation parameters (PT ≥ 1.2 LSN)
- Thrombocytopenia (platelet count <50000)
- Transaminase levels more than 3 times normal
- Impaired kidney function (creatinine >1.5 mg/dL or clearance <60 mL/min/1.73 m2)
- Contraindications for colonoscopy, bowel biopsy, or conscious sedation
- Anemia (grade 1 or higher)
- Use of aspirin, ibuprofen, warfarin, or agents affecting coagulation within 1 week before endoscopy
- Treatment with CYP3A inducers or inhibitors
- Known hypersensitivity or contraindication to study drugs or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Not Yet Recruiting
2
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
Research Team
S
Santiago Moreno Guillen, PhD
CONTACT
E
Erick de la Torre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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