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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

PRO 2000 Gel is designed to be inserted into the vagina to protect women from getting HIV during sex. So far, PRO 2000 Gel has been tested for safety in 136 women from Europe and the United States. This study will evaluate the safety and acceptability of PRO 2000 Gel when used by women in Pune, India. The study will also examine what Indian women and men think about using PRO 2000 Gel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)
• Treatments: Anti-Infective Agents

Criteria

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