Actively Recruiting
Clinical Trial to Eliminate the Latent HIV-1 Reservoir by Administering High Doses of Antiretroviral Drugs in a Randomized Controlled Phase II Study
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-06-25
24
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HIV-1 infection remains a significant global health challenge with social and economic impacts. While standard combination antiretroviral therapy (TAR) helps control the virus and improve quality of life, it does not fully address the viral reservoir that allows HIV to persist. This trial aims to study whether increasing antiretroviral drug levels in lymphatic tissue by administering higher doses can reduce or eliminate this latent HIV reservoir, potentially impacting long-term treatment and inflammation associated with HIV. Participants will be randomly assigned to one of two groups: continuing their usual triple antiretroviral regimen containing an integrase inhibitor or receiving higher doses of three specific antiretroviral drugs (dolutegravir 50 mg every 12 hours, maraviroc 300 mg every 12 hours, and lamivudine 300 mg every 12 hours). This study is open-label and controlled, planned to run for 48 weeks, to assess how increased drug levels affect viral replication and the latent reservoir. During the study, participants will undergo evaluations including measuring the size of the latent HIV reservoir in lymphoid tissue and blood, analyzing intracellular HIV RNA levels, immune activation markers, inflammation, and drug concentrations in blood and gastrointestinal tissue. Safety and tolerability of the higher dose regimen will also be monitored. Participants will be followed for 48 weeks to assess these outcomes and their overall health status.
CONDITIONS
Brief 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 provide written informed consent after understanding the study design and risks
- Age between 18 and 60 years
- Understand the study purpose and available for visits and procedures
- Diagnosed with HIV and followed in HIV consultations
- On antiretroviral treatment with a triple regimen containing an integrase inhibitor
- Undetectable plasma viral load (<50 copies HIV RNA) 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
- For women of childbearing age, negative urine pregnancy test within 7 days before treatment start
- Women of childbearing age and male partners must agree to use effective contraception until 6 months after last dose
You will not qualify if you...
- Chronic Hepatitis B (HBsAg positive)
- Untreated chronic Hepatitis C
- Viral tropism X4
- Pregnancy or planning pregnancy during the study
- Lactation
- Abnormal coagulation parameters (PT ≥1.2 LSN)
- Thrombocytopenia (platelet count <50000)
- Transaminases >3 times normal values
- Impaired renal function (plasma creatinine >1.5 mg/dl, creatinine 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 other anticoagulants within 1 week before endoscopy
- Concomitant treatment with cytochrome CYP3A inducers or inhibitors
- Known hypersensitivity to study drugs or investigator-determined contraindications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive either their usual triple antiretroviral therapy or high doses of triple antiretroviral drugs including dolutegravir, maraviroc, and lamivudine.
Regular visits during treatment as per protocol
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
E
Erick de la Torre
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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