NARI Trial on the Safety of PRO 2000 Vaginal Gel

[Guest guest]

Dear FORUM,

This is to inform you about some of the latest research talking place

in India. National AIDS Research Institute (NARI) study on " Safety and

Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in

India " is significant. It offers a women controlled HIV prevention option.

According to the Principal investigator of the study Dr. Smita Joshi "

This Phase I safety and acceptability study of 0.5% of PRO 2000

vaginal gel has been completed. The study was done among 42 HIV

un-infected women for the safety of 14 consecutive days of

intra-vaginal use of 0.5% Pro 2000. Overall the product was found safe

for twice daily use for 14 days. The data is still being analysed and

we will be publishing the study results. Regards "

Joe

Moderator

e FORUM

____________

The details of the research project on the " Safety and Acceptability

of PRO 2000 Vaginal Gel in HIV Uninfected Women in India "

This study is no longer recruiting patients.

Sponsors and Collaborators:

National Institute of Allergy and Infectious Diseases (NIAID)

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)

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 Treatment or Intervention Phase

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

MedlinePlus related topics: AIDS

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)

Further Study Details:

Expected Total Enrollment: 120

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 above, Genders Eligible for

Study: Both

Accepts Healthy Volunteers

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

Location Information

Study chairs or principal investigators

Smita N. Joshi, MBBS, Study Chair, National AIDS Research

Institute, Pune, India (Research Officer, Epidemiology,

E-mail address: <sjoshi@...>

J. Reynolds, MD, FRCP©, Study Chair, s Hopkins

University Department of Medicine

Publications

Morrow K, Rosen R, Richter L, Emans A, Forbes A, Day J, Morar N,

Maslankowski L, Profy AT, 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- LE, Poindexter III AN, Frezieres RG, Walsh TL,

CW, 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, 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

Record last reviewed: October 2004

Record first received: April 16, 2004

ClinicalTrials.gov Identifier: NCT00081640

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on 2005-01-19