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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04653194
Eligibility Criteria:
Inclusion Criteria:
1. Is male or female aged 18 years or over.
2. Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated.
3. Is capable of giving informed consent.
4. Is willing to comply with the protocol requirements
5. A female may be eligible to enter and participate in the study if she:
1. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
2. is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and agrees to use one of the methods of contraception to avoid pregnancy indicated in Appendix 4 during the study and for a period of 12 weeks after the study.
6. Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 4) must be using an adequate method of contraception as listed in Appendix 4 to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study;
Exclusion Criteria:
1. Infected by HIV-2
2. On PEP
3. Use of medications that are know to interact with either treatment B or S
4. Unstable health conditions that according to the opinion of the Investigator suggest the individual should not take part in the trial (including unstable liver diseases, possible opportunistic infections, etc)
5. Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 4.4; Withdrawal Criteria and Section 10.4; Collection and Follow up of Adverse Events if pregnancy does occur in a trial subject)
6. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomisation.
7. Known acute or chronic viral hepatitis including, but not limited to, A, B, or C
8. Any investigational drug within 30 days prior to the trial drug administration
9. Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04653194
Study Brief:
Protocol Section:
NCT04653194