Status and phase
Conditions
Treatments
About
HIV Open-label Prevention Extension (HOPE).
Full description
A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Women must meet all of the following criteria to be eligible for inclusion in the study
Exclusion criteria
Women who meet any of the following criteria will be excluded from the study
Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial
Per participant report at Screening:
Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)
With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period
Currently breastfeeding
Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines
At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
Has any of the following laboratory abnormalities at Screening Visit:
Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Primary purpose
Allocation
Interventional model
Masking
1,456 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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