Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00081640

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: PRO 2000/5 Gel (P)	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Pro 2000

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

120

Detailed Description:

Topical microbicides are designed to prevent the sexual transmission of HIV and other disease pathogens. PRO 2000/5 Gel (P), or PRO 2000, is a vaginal microbicide that has been evaluated in Phase I safety trials in Europe and the U.S. PRO 2000 Gel is easily manufactured, highly stable, and highly water-soluble. The aqueous gel formulation contains a synthetic carbomer, a lactic acid/lactate buffer, and preservatives. In vitro, PRO 2000 Gel has been shown to suppress infection by herpes viruses, Chlamydia trachomatis, Neisseria gonorrhoeae, and a wide range of HIV-1 isolates. This study will evaluate the safety and acceptability of PRO 2000 Gel in HIV uninfected women in Pune, India. The study is a precursor to a larger Phase II/III study of PRO 2000 Gel.

Participants in this study will be sexually active HIV uninfected women at either low or high risk for HIV infection. Male partners of these women will also be enrolled in the study. Participants will be asked to apply PRO 2000 Gel twice a day for 14 consecutive days between menses and to have vaginal intercourse with a single male partner, using study-provided male condoms, at least twice per week during the two weeks of PRO 2000 Gel use.

Participants will have a screening visit, an enrollment visit, and 3 study visits during the two weeks of PRO 2000 Gel use; each visit will last about 1 hour. Study visits will include a medical history, gynecologic exam, blood and urine tests, and product acceptability questionnaires. Colposcopy will be performed three times during the study. Participants will also be asked to complete a Daily Study Record about product use and sexual activity and questionnaires about their willingness to use the product and their perceptions of the product.

Four weeks after using PRO 2000 Gel, participants will be asked to participate in a focus group to discuss product acceptability. Participants' male partners will also be asked to participate in focus groups about product use.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081640

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators

Study Chair:	Smita N. Joshi, MBBS	National AIDS Research Institute, Pune, India
Study Chair:	Steven J. Reynolds, MD, FRCP(C)	Johns Hopkins University Department of Medicine

More Information

Additional Information:

Click here for more information about PRO 2000 This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

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.

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):476-483.

Mayer KH, Karim SA, Kelly C, Maslankowski L, Rees H, Profy AT, Day J, Welch J, Rosenberg Z. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS. 2003 Feb 14;17(3):321-329.

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

Study ID Numbers:	HPTN 047
Study First Received:	April 16, 2004
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00081640 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Seronegativity
Vaginal Microbicide

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009