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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03620734
Eligibility Criteria:
Inclusion Criteria:
1. Thai nationality
2. Age 18-40 years old
3. Male-to-female transgender individual
4. PrEP/ART naïve
5. Body mass index 18.5-25 kg/m2
6. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
7. Alanine aminotransferase (ALT) ≤2.5 x ULN
8. Have signed the informed consent form
Exclusion Criteria:
1. Known history of allergy to hormonal or ARV component to be used in the study
2. Male-to-female transgender who underwent orchiectomy
3. Any of the following in HIV-infected participants
* CD4 \< 350 cells/mm3
* History of psychiatric disorder that may be worsening by taking EFV
4. Previous use of injectable GAHT in the past 6 months
5. Current use of any of the following medication:
* Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol
* Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives
* Sedatives: Midazolam or triazolam
* Herbs: Gingko biloba, St John's wort or milk thistle
* Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin
6. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03620734
Study Brief:
Protocol Section:
NCT03620734