Phase
Condition
Hiv
Hiv Infections
Hiv/aids
Treatment
N/AClinical Study ID
Ages 18-40 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Women must meet all of the following criteria to be eligible for inclusion in the study
- Previously enrolled in MTN-020 (ASPIRE)
- Able and willing to provide written informed consent to be screened for and to takepart in the study
- Able and willing to provide adequate locator information, as defined in site SOPs
- HIV-uninfected based on testing performed by study staff at Screening and Enrollment
- Using an effective method of contraception at Enrollment, and intending to use aneffective method for the duration of study participation; effective methods includehormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs)
- At Screening and Enrollment, agrees not to participate in other research studiesinvolving drugs, medical devices, vaginal products, or vaccines for the duration ofstudy participation
Exclusion
Exclusion Criteria: Women who meet any of the following criteria will be excluded from the study 1. Study product use permanently discontinued in response to an AE or safety relatedconcern while taking part in the MTN-020 (ASPIRE) trial 2. Per participant report at Screening: 1. Plans to relocate away from the study site during study participation 2. Plans to travel away from the study site for more than three consecutive monthsduring study participation 3. Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP) 4. With the exception of MTN-020 (ASPIRE), participation in any other research studyinvolving drugs, medical devices, vaginal products, or vaccines, within 60 days ofenrollment 5. Is pregnant at Screening/Enrollment or planning to become pregnant in theparticipant's anticipated study participation period 6. Currently breastfeeding 7. Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STIor reproductive tract infection (RTI) requiring treatment per WHO guidelines 8. At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by studystaff) as per the Division of AIDS Table for Grading the Severity of Adult andPediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies 9. Has any of the following laboratory abnormalities at Screening Visit: 1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3* 2. Creatinine > Grade 3* 3. Hemoglobin > Grade 3* 4. Platelet count > Grade 3* 5. Pap result ≥ Grade 3 according to the Female Genital Grading Table for Use inMicrobicide Studies Addendum 1 to the DAIDS Table for Grading Adult and PediatricAdverse Events, Version 1.0, December 2004 (Clarification dated August 2009) 10. Has any significant medical condition or other condition that, in the opinion of theIoR/designee, would preclude informed consent, make study participation unsafe,complicate interpretation of study outcome data, or otherwise interfere with achievingthe study objectives
Study Design
Study Description
Connect with a study center
Johns Hopkins University Research Project
Blantyre,
MalawiSite Not Available
Malawi Clinical Research Center
Lilongwe,
MalawiSite Not Available
Medical Research Council of South Africa
Westville, Durban 3630
South AfricaSite Not Available
WRHI Clinical Research Center
Johannesburg, Gauteng
South AfricaSite Not Available
Botha's Hill Clinical Research Center
Durban, Kwa-Zulu Natal
South AfricaSite Not Available
Chatsworth Clinical Research Center
Durban, Kwa-Zulu Natal
South AfricaSite Not Available
Prevention for HIV and AIDS Project
Pinetown, KwaZulu Natal
South AfricaSite Not Available
Isipingo Clinical Research Center
Durban, KwaZulu-Natal
South AfricaSite Not Available
Tongaat Clinical Research Center
Durban, KwaZulu-Natal
South AfricaSite Not Available
Verulam Clinical Research Center
Durban, KwaZulu-Natal 4340
South AfricaSite Not Available
Emavundleni Research Centre
Cape Town, Western Cape 7750
South AfricaSite Not Available
eThekwini Clinical Research Center
Durban, 4001
South AfricaSite Not Available
Wits Reproductive Health and HIV Institute Research Centre
Johannesburg,
South AfricaSite Not Available
MU-JHU Research Collaboration
Kampala,
UgandaSite Not Available
Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center
Kampala,
UgandaSite Not Available
Seke South Clinical Research Center
Harare,
ZimbabweSite Not Available
Spilhaus Clinical Research Center
Harare,
ZimbabweSite Not Available
Zengeza Clinical Research Center
Harare,
ZimbabweSite Not Available
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