Status:
COMPLETED
Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Microbicide Trials Network
Conditions:
HIV Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fum...
Detailed Description
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and anti-HIV ...
Eligibility Criteria
Inclusion
- Willing to provide adequate locator information
- Sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
- Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for duration of study.
- Agree to use effective method of contraception. More information on this criterion can be found in the protocol.
Exclusion
- HIV infected
- Known adverse reaction to any of the study products
- Known adverse reaction to latex
- Pathologic bone fracture not related to trauma
- Non-therapeutic injection drug use in the 12 months prior to screening
- Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment
- Last pregnancy outcome 42 days or less prior to enrollment
- Gynecologic or genital procedure 42 days or less prior to enrollment
- Participation in any other research study involving drugs, medical devices, or vaginal products 30 days or less prior to enrollment
- Currently using spermicide, interferon or interleukin therapy, or certain medications. More information on this criterion can be found in the protocol.
- Any significant uncontrolled active or chronic disease. More information on this criterion can be found in the protocol.
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
- Intends to become pregnant in the 24 months after enrollment
- Plans to relocate or travel away from the study site for more than 8 consecutive weeks in the 24 months after enrollment
- Urinary tract infection
- Pelvic inflammatory disease, an STI, or reproductive tract infection requiring treatment
- Grade 2 or higher pelvic exam finding
- Any condition that, in the opinion of the investigator, would interfere with the study
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
5029 Patients enrolled
Trial Details
Trial ID
NCT00705679
Start Date
August 1 2009
End Date
August 1 2012
Last Update
October 29 2021
Active Locations (15)
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1
Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
Johannesburg, Gauteng, South Africa, 2001
2
Soweto MTN CRS
Johannesburg, Gauteng, South Africa
3
Overport CRS
Asherville, KwaZulu-Natal, South Africa, 4091
4
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa, 4030