Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
Brief Summary: This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.


Options:
A: Inclusion Criteria:

* Age 18-40 years (inclusive)
* Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
* Able and willing to provide adequate locator information for study retention purposes.
* Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
* HIV negative on testing performed by study staff within 30 days of enrolment.
* Have a negative pregnancy test which was performed by study staff within 21 days of enrolment
* Agree to use a non-barrier form of contraceptive
* Agree to adhere to study visits and procedures

Exclusion Criteria:

* History of adverse reaction to latex.
* Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):

  * To travel away from the study site for more than 30 consecutive days.
  * To relocate away from the study site.
  * To become pregnant
  * To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.
* Has a creatinine clearance \<50ml/min, as estimated using the method of Cockcroft and Gault(33).
* Has active Hepatitis B infection (since January 2009)
* Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
* Has in the past year participated in any research related to any vaginally applied product/s.
* Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.
* Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
B: Inclusion Criteria:

* HIV negative and agree to be tested for HIV and told their results at all visits during the study
* Aged 16 - 40 years of age
* Have had at least one vaginal intercourse within the last three months
* Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
* Provide locator information to study staff throughout the trial
* Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
* Citizen or permanent resident of South Africa
* Resident for the past year and intends to reside in the catchment area of the site for the next two years
* During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.

Exclusion Criteria:

* Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
* Within four weeks of last pregnancy outcome at the time of enrolment
* Pap smear at screening is graded as carcinoma.
* Injected illicit drugs in the 12 months prior to screening
* Participating in any other clinical trial/HIV prevention study
C: Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study.

Inclusion Criteria:

* HIV uninfected
* Have had sexual intercourse at least once in the 3 months prior to study entry
* Able to provide adequate contact information to study officials for purposes of follow-up

Exclusion Criteria:

* History of adverse reaction to latex
* Nonmedical injection drug use in the 12 months prior to study entry
* Vaginal intercourse more than an average of two times per day in the 2 weeks prior to study entry
* Plan to become pregnant in the 30 months after study entry
* Plan to travel away from the study site for more than 3 consecutive months in the 30 months after study entry
* Plan to relocate away from the study site in the 30 months after study entry
* Participation in another clinical trial of a vaginal product
* Pregnant within 42 days of study entry
* Have a sexually transmitted disease or other reproductive tract infection diagnosed by study staff
* Abnormal pelvic exam indicating deep epithelial disruption
* Condition that, in the opinion of the investigator, may interfere with the study
* Liver or kidney function abnormality of Grade 3 or higher
* Blood or blood clotting abnormality of Grade 4 or higher
D: Inclusion Criteria:

* Normal menstrual history with regular cycles and with a minimum of 21 days between menses
* Low risk for HIV/STI infection. More information on this criterion can be found in the protocol.
* Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study

Exclusion Criteria:

* HIV-infected
* Menopausal
* Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
* Menstruating at screening or enrollment visits
* Urinary tract infection at screening
* Positive chlamydia, gonorrhea, or trichomonas result at screening
* Abnormal Pap smear
* Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
* Currently participating in a research study of other vaginal products
* History of intermenstrual bleeding within 3 months prior to study entry
* Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry
* Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry
* Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry
* Vaginal or anal intercourse during the 48 hours prior to study entry
* Oral antibiotics within 7 days of study entry
* Pregnant, less than 6 months postpartum, or breastfeeding

Answer: A