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New treatment option for HIV-1-infection
Official title Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
ClinicalTrials.gov ID: NCT06640192
What this study is testing
What is Standardised triple antiretroviral therapy?
Standardised triple antiretroviral therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv-1-infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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).
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.