Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of SAVVY and HIV in Ghana
Brief Summary: Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.


Options:
A: Inclusion Criteria:

* 18 to 35 year old women
* HIV negative
* More than one sexual partner in past 3 months
* Average of 3 coital acts per week
* Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

* HIV positive
* Pregnant
B: 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
C: Inclusion Criteria:

* Confirmed age 18-40 years (inclusive)
* Able and willing to provide written informed consent
* Able and willing to provide adequate locator information for study retention and safety purposes
* Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening
* HIV negative on two rapid tests performed by study staff within 30 days of enrolment (see algorithm in Appendix 3).
* No evidence of glycosuria
* No evidence of proteinuria greater than trace\*
* No history of pathological bone fractures
* Have a negative pregnancy test
* Women currently breastfeeding may be enrolled in the study
* Agree to use a study-approved effective non-barrier form of contraception
* Agree to adhere to study visits and procedures
* Willing to use study gel as advised
* Not using or taking any of the following groups of medications:

  * Nephrotoxic agents
  * Drugs that slow renal excretion
  * Immune system modulators
  * Other antiretrovirals

Exclusion Criteria:

* History of adverse reaction to latex.
* Plans any of the following during the study period

  * 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.
* If in the opinion of the examining clinician, is not sexually active
* Inadequate renal function (serum creatinine greater than 1.5mg/dl and creatinine clearance less than 50ml/min, as estimated using the method of Cockcroft and Gault96 )
* Grade 3 and above ALT and AST at screening or any clinical sign of liver disease ( e.g. ascites, hepatomegaly, jaundice)
* Abnormal serum phosphate levels (Grade 3 and above)
* Has a clinically apparent finding on speculum pelvic examination (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with speculum pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
* Received previously or receiving an experimental HIV vaccine
* Currently participating in another HIV prevention intervention study or participation in any other clinical trial with a biomedical intervention in the last six months
* 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 been completed.
* Any clinical evidence of untreated cervical abnormalities
* 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.
D: 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

Answer: A