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

NCT00081640 | Completed Phase 1

• 1 other identifier: HPTN 047
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections

Keywords

HIV Seronegativity; Vaginal Microbicide

Interventions

PRO 2000/5 Gel (P) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Age 18 years or older
• HIV uninfected
• No STD symptoms at study entry

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Related Publications (5)

• Morrow K, Rosen R, Richter L, Emans A, Forbes A, Day J, Morar N, Maslankowski L, Profy AT, Kelly C, Abdool Karim SS, Mayer KH. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. J Womens Health (Larchmt). 2003 Sep;12(7):655-66. doi: 10.1089/154099903322404302.

  PMID: 14583106 BACKGROUND

• Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter III AN, Frezieres RG, Walsh TL, Kelly CW, Richardson BA, Van Damme L, Celum CL. Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men. J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-83. doi: 10.1097/00126334-200308010-00008.

  PMID: 12869836 BACKGROUND

• Mayer KH, Karim SA, Kelly C, Maslankowski L, Rees H, Profy AT, Day J, Welch J, Rosenberg Z; HIV Prevention Trials Network (HPTN) 020 Protocol Team. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS. 2003 Feb 14;17(3):321-9. doi: 10.1097/00002030-200302140-00005.

  PMID: 12556685 BACKGROUND

• Trager RS. Microbicides. Raising new barriers against HIV infection. Science. 2003 Jan 3;299(5603):39. doi: 10.1126/science.299.5603.39. No abstract available.

  PMID: 12511630 BACKGROUND

• Smita J, Soma D, Beverly B, Albert P, JoAnn K, Fang G, Missy C, Lydia ST, Anjali P, Arun R, Sanjay M, Steven J R; HIV Prevention Trial Network (HPTN) 047 Protocol Team. Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India. AIDS Res Ther. 2006 Feb 20;3:4. doi: 10.1186/1742-6405-3-4.

  PMID: 16504023 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Smita N. Joshi, MBBS

  National AIDS Research Institute (Pune, India)

  STUDY CHAIR

• Steven J. Reynolds, MD, FRCP(C)

  Johns Hopkins University Department of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 16, 2004
• First Posted: April 19, 2004
• Last Updated: December 23, 2009

Record last verified: 2006-11