Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India

Inclusion Criteria for All Female Participants:

• Age 18 to 45
• HIV uninfected
• Regular menstrual cycle of at least 21 days or no menstrual cycle because of long-acting progestin use
• No change in hormonal contraceptive use in the 3 months prior to study entry
• Agree to use acceptable methods of contraception during the study
• Normal Pap smear at screening or in the 3 months prior to study entry
• Sexually active with a single male sexual partner who is eligible for the study
• Agree to abstain from sexual intercourse for 48 hours before the enrollment visit
• Willing to complete Daily Study Records
• Agree to follow study directions about PRO 2000 Gel use and sexual activity during the study

Additional Inclusion Criteria for Female Participants at Higher Risk for HIV Infection:

• Sexually transmitted disease (STD) in the 3 months prior to study entry
• Current male partner has had an STD in the 3 months prior to study entry

Inclusion Criteria for Male Partners of Female Participants:

• Age 18 years or older
• HIV uninfected
• No STD symptoms at study entry
• Agree to abstain from sexual intercourse for 48 hours before the enrollment visit
• Agree to have vaginal intercourse only with partner who is taking part in the study
• Agree to have vaginal intercourse at least twice a week while in the study and to use study provided male condoms

Exclusion Criteria for All Female Participants:

• Menopausal
• Breastfeeding
• Used non-therapeutic intravenous drugs within 1 year of study
• Currently pregnant or have been pregnant in the 3 months prior to study entry
• Serious liver, kidney, or blood abnormalities
• Urinary tract infection as determined by positive urine culture
• Genital abnormality
• History of adverse reaction to anticoagulants
• History of sensitivity or allergy to latex
• Used any spermicide or spermicidally lubricated condom in the week prior to study entry
• Participated in any investigational drug trial in 30 days prior to study entry
• Used an intrauterine contraceptive device in the 3 months prior to study entry
• Abnormal Pap smear in the 3 months prior to study entry
• Gynecological surgery in the 3 months prior to study entry
• Breakthrough menstrual bleeding in the 3 months prior to study entry
• Vaginal bleeding during or following intercourse in the 3 months prior to study entry

Additional Exclusion Criteria for Female Participants at Low Risk for HIV Infection:

• STD or pelvic inflammatory disease in the 3 months prior to study entry
• Current male partner has had an STD in the 3 months prior to study entry
• Current male partner has injected non-therapeutic drugs in the 3 months prior to study entry
• Signs on pelvic exam consistent with an STD other than bacterial vaginosis

Exclusion Criteria for Male Partners of Female Participants

• History of adverse reaction to latex
• Refuse examination or treatment for an STD or STD symptoms