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HIV InfectionsPhase 1NCT00081640

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

A Phase 1 study testing PRO 2000/5 Gel (P) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
PRO 2000/5 Gel (P)
How many people
120 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • History of adverse reaction to latex
  • Refuse examination or treatment for an STD or STD symptoms

About this study

Official title: Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)

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.

Read the 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.

Conditions
HIV Infections
Being tested
PRO 2000/5 Gel (P)
Keywords
HIV Seronegativity, Vaginal Microbicide
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO 2000/5 Gel (P)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2004 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081640
Sponsor's protocol ID
HPTN 047
Status last verified
Nov 2006
First submitted
16 Apr 2004
Last updated
23 Dec 2009
Results posted
No

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. doi: 10.1089/154099903322404302.

    PubMed 14583106

  • 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.

    PubMed 12869836

  • 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.

    PubMed 12556685

  • 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.

    PubMed 12511630

  • 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.

    PubMed 16504023

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRO 2000/5 Gel (P) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081640, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2009.

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