HIV-1-infectionPhase 2NCT06640192
Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
A Phase 2 study testing Standardised triple antiretroviral therapy and High doses Triple therapy antiretroviral drugs in people with HIV-1-infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Standardised triple antiretroviral therapy and High doses Triple therapy antiretroviral drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSpain
- Study dates
- 30 May 2025to 5 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid
About this study
Official title: 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.
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.
Read the detailed description
Data on the penetration of antiretrovirals into the tissues of long-term treated HIV patients are very limited. Previous pharmacokinetic studies indicate that tissue concentrations of the drug are much lower than those observed in plasma of HIV-infected patients or healthy volunteers. In addition, another study has reported that intracellular levels of antiretrovirals are much lower in lymphoid tissues than in peripheral blood after 6 months of TAR initiation, and these levels correlated inversely with ongoing viral replication.
In the line of research that we are raising, a previous study has reported a decrease in intracellular HIV RNA in lymphoid tissue when dolutegravir was administered at higher than usual doses. This is an important advance and new studies should be implemented with a design that allows to potentiate this strategy and significantly decrease the size of the viral reservoir in tissues.
If the hypothesis of the project, which consists mainly in the reduction or elimination of the HIV reservoir, is demonstrated, there would be very important consequences in the area of functional cure of HIV and/or reduction of chronic persistent inflammation, which could generate changes in conventional treatment schemes with great scalability. In addition, it is possible that by decreasing levels of persistent viral replication, an improvement in levels of immune activation and inflammation may also be observed, which would contribute positively to the overall health of the patient. Oral antiretroviral medication is proposed in order to compound a three-drug antiretroviral regimen. The three antiretroviral drugs have been chosen because they are the only ones that allow administration at higher doses without causing increased toxicity: dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h.
- Conditions
- HIV-1-infection
- Being tested
- Standardised triple antiretroviral therapy, High doses Triple therapy antiretroviral drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised triple antiretroviral therapyDrug
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.
High doses Triple therapy antiretroviral drugsDrug
dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Triple therapy antiretroviral drugs on their usual regimen containing an integrase inhibitor Receives: Drug: Standardised triple antiretroviral therapy |
| Intervention | Experimental | High doses of triple therapy antiretroviral drugs: dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h. Receives: Drug: High doses Triple therapy antiretroviral drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 in lymphoid tissue and peripheral blood after administration of high doses of antiretroviral drugs.
Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
Measured: 48 weeks
Secondary outcomes (6)
To evaluate the variation of intracellular HIV RNA in total CD4+ T cells and memory phenotypes from baseline to weeks 24 and 48 in both blood and lymphoid tissue.
HIV replication by measuring cell-associated HIV RNA (ca-HIV-RNA) and HIV RNA levels in blood and lymphoid tissue.
Measured: 48 weeks
To compare changes in distribution and activation markers ( CD25, HLA-DR among others) in T-cell subpopulations (naïve and memory phenotypes).
Activation/inflammation markers (HLA-DR, CD25, among others) in blood and intestinal T-cell subpopulations.
Measured: 48 weeks
To evaluate the effects of the intervention on markers of inflammation and bacterial translocation.
Levels of plasma biomarkers of activation/inflammation and bacterial translocation (IL-6, CRP, TNF, sCD14, among others).
Measured: 48 weeks
To determine antiretroviral drug concentrations in blood and gastrointestinal tract tissue.
Antiretroviral drug concentrations in lymphoid tissue and peripheral blood.
Measured: 48 weeks
To correlate markers of viral persistence (intact HIV DNA and ca-HIV RNA) with drug concentrations, as well as with activation and inflammation parameters of cell subpopulations and plasma.
Colonoscopy examination and collection of intestinal tissue samples (biopsy) for determination of viral reservoir variables (proviral DNA and intracellular HIV RNA) and antiretroviral drug levels.
Measured: 48 weeks
Incidence of Adverse Events with experimental treatment regimen (Safety and Tolerability)
Incidence and types of adverse reactions.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 May 2025
- Primary completion8 May 2026
- Study completion5 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Moreno Guillen, Principal investigator, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640192
- Sponsor's protocol ID
- DOSAGE
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06640192
- Acronym / sponsor ID
- DOSAGE
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data on the penetration of antiretrovirals into the tissues of long-term treated HIV patients are very limited. Previous pharmacokinetic studies indicate that tissue concentrations of the drug are much lower than those observed in plasma of HIV-infected patients or healthy volunteers. In addition, another study has reported that intracellular levels of antiretrovirals are much lower in lymphoid tissues than in peripheral blood after 6 months of TAR initiation, and these levels correlated inversely with ongoing viral replication.
In the line of research that we are raising, a previous study has reported a decrease in intracellular HIV RNA in lymphoid tissue when dolutegravir was administered at higher than usual doses. This is an important advance and new studies should be implemented with a design that allows to potentiate this strategy and significantly decrease the size of the viral reservoir in tissues.
If the hypothesis of the project, which consists mainly in the reduction or elimination of the HIV reservoir, is demonstrated, there would be very important consequences in the area of functional cure of HIV and/or reduction of chronic persistent inflammation, which could generate changes in conventional treatment schemes with great scalability. In addition, it is possible that by decreasing levels of persistent viral replication, an improvement in levels of immune activation and inflammation may also be observed, which would contribute positively to the overall health of the patient. Oral antiretroviral medication is proposed in order to compound a three-drug antiretroviral regimen. The three antiretroviral drugs have been chosen because they are the only ones that allow administration at higher doses without causing increased toxicity: dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Standardised triple antiretroviral therapyTriple therapy antiretroviral drugs on their usual regimen containing an integrase inhibitor |
| Intervention | Experimental | Drug: High doses Triple therapy antiretroviral drugsHigh doses of triple therapy antiretroviral drugs: dolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- Chronic Hepatitis B (HBsAg +)
- Untreated chronic hepatitis C
- Viral tropism X4
- Pregnancy or planning to become pregnant during the course of the study.
- Lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised triple antiretroviral therapypatients 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. | Drug | Control |
| High doses Triple therapy antiretroviral drugsdolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h | Drug | Intervention |
Primary outcome
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 in lymphoid tissue and peripheral blood after administration of high doses of antiretroviral drugs.
Time frame: 48 weeks
Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
6 secondary outcomes
To evaluate the variation of intracellular HIV RNA in total CD4+ T cells and memory phenotypes from baseline to weeks 24 and 48 in both blood and lymphoid tissue.
Time frame: 48 weeks
To compare changes in distribution and activation markers ( CD25, HLA-DR among others) in T-cell subpopulations (naïve and memory phenotypes).
Time frame: 48 weeks
To evaluate the effects of the intervention on markers of inflammation and bacterial translocation.
Time frame: 48 weeks
To determine antiretroviral drug concentrations in blood and gastrointestinal tract tissue.
Time frame: 48 weeks
To correlate markers of viral persistence (intact HIV DNA and ca-HIV RNA) with drug concentrations, as well as with activation and inflammation parameters of cell subpopulations and plasma.
Time frame: 48 weeks
Incidence of Adverse Events with experimental treatment regimen (Safety and Tolerability)
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Moreno Guillen principal investigator
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardised triple antiretroviral therapy and High doses Triple therapy antiretroviral drugs in people with HIV-1-infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 in lymphoid tissue and peripheral blood after administration of high doses of antiretroviral drugs. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.