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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02191293
Eligibility Criteria:
Inclusion Criteria:
* Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
* Women can only be included, if a test has excluded pregnancy
* Only women can be included, who use a reliable means of contraception during the observational study
Exclusion Criteria:
* Known sensitivity to Viramune or one of its excipients
* Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
* For females:
* Pregnancy
* Breast-feeding
* Insufficient or unreliable contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02191293
Study Brief:
Protocol Section:
NCT02191293