HIV InfectionsPhase 1NCT00006207
Safety and Tolerability of the Vaginal Gel PRO 2000/5
A Phase 1 study testing PRO 2000 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily. Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PRO 2000
- How many people
- 60 participants
- Where
- 1 siteUnited States
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers may be eligible for this study if they:
- Are female and 18-45 years of age.
- Are willing and able to complete daily study records.
- Are willing to undergo clinical exams and testing.
- Either have regular menstrual periods or do not menstruate due to use of hormones.
- Agree to stop using female barrier methods of birth control during the study.
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- Additionally, volunteers may be eligible for HIV-negative groups in this study if they:
- Have not changed their use of hormonal birth control over the last 3 months.
- Are HIV-negative.
- Have a single male partner at low-risk for HIV infection and agree that he can be asked for his consent.
- Agree to the following: To have vaginal intercourse 2 or more times a week; to use condoms provided by the study for each act of intercourse; to use the gel as directed; not to be in similar studies; not to receive oral sex; not to use IV drugs, except for medical treatment; not to use any other vaginal products; not to douche; and not to use vaginal drying agents.
- Additionally, volunteers may be eligible for the HIV-positive group in this study if they:
- Are HIV-positive.
- Have a CD4 count greater than 200 cells/mm3.
- Have a normal Pap smear at screening.
- Are on stable anti-HIV drug therapy.
- Agree to have no sexual intercourse during the study.
- Have HIV care by qualified medical caregivers.
- Agree to allow study staff access to their HIV medical care information.
- Agree to the following: To use the gel as directed; not to use IV drugs other than for medical treatment; not to use any other vaginal products; not to participate in similar studies; not to receive oral sex; not to douche; and not to use any vaginal drying agents.
Who cannot join
- Volunteers will not be eligible for this study if they:
- Are menopausal.
- Have certain liver, kidney, or blood problems.
- Have genital problems such as sores.
- Are allergic to anything used in the study, including latex.
- Have used spermicides or condoms treated with spermicides within the week before enrollment.
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- Have been in another drug study within the past 30 days.
- Have participated in this trial before and study gel has been permanently discontinued.
- Have had an IUD or begun using hormonal birth control, or had an abnormal Pap smear, a pregnancy, an abortion, gynecologic surgery, breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months.
- Have had or received treatment for sexually transmitted diseases in the past 3 months.
- Show signs, on a pelvic exam, indicating a sexually transmitted disease or other genital tract problems.
- Used IV drugs, except for medical reasons, within the past year.
- Received antibiotics in the last 14 days.
- Have had a reaction to an anticoagulant (such as warfarin or heparin).
- Are pregnant or breast-feeding.
- Have a positive urine culture.
Trial locations and contacts
1 site in 1 country.
United States1 site
Julia Welch
Research Triangle Park, North Carolina, 27709
About this study
Official title: A Phase I Multicenter Dose Escalation Safety and Acceptability Study of the Investigational Vaginal Microbicide Agent PRO 2000/5 Gel (P)
The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.
Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.
Read the detailed description
Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that multiple application of the gel was safe and well tolerated in healthy, sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated. Because genital ulceration and inflammation may increase the risk of HIV infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for study participants with active sexual behavior.
Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days. HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix. Women and their male partners are questioned about gel usage.
- Conditions
- HIV Infections
- Being tested
- PRO 2000
- Keywords
- HIV Seropositivity, Dose-Response Relationship, Drug, HIV Seronegativity, Mucous Membrane, Ulcer, Vagina, Anti-HIV Agents, Sexual Abstinence, Irritants, PRO 2000
- Medical subject headings
- HIV Infections, HIV Seropositivity, Ulcer, Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO 2000Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Procept
- Investigators
- Ken Mayer, Study chairSalim Abdool Karim, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006207
- Sponsor's protocol ID
- HIVNET 020
- Status last verified
- Jun 2003
- First submitted
- 11 Sep 2000
- Last updated
- 30 Jul 2008
- Results posted
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multicenter Dose Escalation Safety and Acceptability Study of the Investigational Vaginal Microbicide Agent PRO 2000/5 Gel (P)
- ClinicalTrials.gov ID
- NCT00006207
- Acronym / sponsor ID
- HIVNET 020
- Conditions
- HIV Infections
- Keywords
- HIV Seropositivity, Dose-Response Relationship, Drug, HIV Seronegativity, Mucous Membrane, Ulcer, Vagina, Anti-HIV Agents, Sexual Abstinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Procept
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.
Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.
Detailed description
Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that multiple application of the gel was safe and well tolerated in healthy, sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated. Because genital ulceration and inflammation may increase the risk of HIV infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for study participants with active sexual behavior.
Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days. HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix. Women and their male partners are questioned about gel usage.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Are female and 18-45 years of age.
- Are willing and able to complete daily study records.
- Are willing to undergo clinical exams and testing.
- Either have regular menstrual periods or do not menstruate due to use of hormones.
- Agree to stop using female barrier methods of birth control during the study.
Key exclusion criteria (16 listed)
- Are menopausal.
- Have certain liver, kidney, or blood problems.
- Have genital problems such as sores.
- Are allergic to anything used in the study, including latex.
- Have used spermicides or condoms treated with spermicides within the week before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO 2000 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
- Background: PubMed 12556685Mayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Mayer study chair
Salim Abdool Karim study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO 2000 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 16 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 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 NCT00006207, which also lists 1 linked publication.
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 30 Jul 2008; AzTrials last refreshed its copy on 8 Nov 2026.