Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT06640192
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06640192
Study Brief:
Protocol Section:
NCT06640192