AzTrials
AzTrials

HIV InfectionsPhase 1NCT00028132

Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel

A Phase 1 study testing Tenofovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected and HIV-uninfected women. The majority of new HIV infections occur through heterosexual contact. A product that stops or slows the replication of HIV during sexual contact is needed. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Tenofovir
How many people
120 participants
Where
5 sitesUnited States
Study dates
Start not givento Dec 2005
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All female participants may be eligible for this study if they:
  • Are between 18 and 45 years of age.
  • Have a menstrual cycle with at least 21 days between periods or have not menstruated for at least 6 months.
  • Agree from the time of Screening Visit until the Day 14 Follow-up Visit to: a) not use IV drugs (except for therapeutic use) and b) not participate in other microbicide or contraceptive studies.
  • Agree not to take part in the following activities for at least 48 hours before the study enrollment visit (Day 0) until the Day 14 Follow-up Visit: anal intercourse; douching; oral contact with the vagina; penetration of the vagina by fingers, sex toys, or any other objects; use of any vaginal product, including lubricants, drying agents, feminine hygiene products, diaphragms, and cervical caps.
  • Agree to insert the PMPA gel in the exact way it is specified.
Show all 22Show fewer
  • Abstinent Women (Groups A1-A4, C, and V) may be eligible for this study if they:
  • Agree to abstain from vaginal intercourse from 48 hours before study until Day 14.
  • HIV-infected abstinent women (C) must be HIV infected; have a CD4 count of at least 200/mm3 at time of screening and within 6 months prior to screening, and a viral load of 10,000 copies/ml or less if on anti-HIV therapy or have a viral load of less than 55,000 if not on anti-HIV therapy; provide study staff access to HIV medical records and be under medical care for HIV management; and be on stable anti-HIV therapy (if any) for 1 month before screening and expect to stay on that therapy throughout the study.
  • Sexually Active Women (Groups B and D) may be eligible for this study if they:
  • Agree to abstain from vaginal intercourse for 48 hours before study start.
  • Agree to tell their mutually monogamous male sexual partner about their participation in the trial and of requirements from Day 0 until Day 14 to have vaginal intercourse at least twice weekly and to use a study-provided male latex condom for every sexual episode.
  • HIV-uninfected sexually active women (B) must currently have a single male HIV-uninfected sexual partner who is at low risk for HIV infection and who can be included in the study.
  • HIV-infected sexually active women (D) must have a CD4 count of at least 200/mm3 at time of screening and within 6 months prior to screening, and a viral load of 10,000 copies/ml or less if on anti-HIV therapy or have a viral load of less than 55,000 if not on anti-HIV therapy; provide study staff access to HIV medical records and be under medical care for HIV management; be on stable anti-HIV therapy (if any) for 1 month before screening and expect to stay on that therapy throughout the study; and currently have a single male HIV-infected sexual partner who can be included in the study.
  • Male sexual partners of sexually active participants (Groups B and D) must be:
  • At least 18 years old and in a relationship with the study participant for at least 3 months and be willing to maintain this relationship for the entire study.
  • At low risk for HIV infection and be HIV-uninfected if female partner is HIV-uninfected (B) or be HIV-infected if female partner is HIV-infected (D).
  • Able and willing to have vaginal intercourse with only the study participant at least 2 times per week, and to use study-provided lubricated male condoms each time during study.
  • Willing to not have vaginal intercourse for 48 hours before Day 0.
  • Willing to abstain from the following from 48 hours before Day 0 until the end of study product use: anal intercourse, oral contact with the vagina, and penetration of the vagina by fingers, sex toys, or any other objects.
  • Willing to take part in an interview after the study and undergo clinical evaluations.
  • (This study has been changed to expand the CD4 cell count criterion for Groups C and D.)

Who cannot join

  • Female participants may not be eligible for this study if they:
  • Have gone through menopause.
  • Have had a hysterectomy.
  • Are breast-feeding.
  • Are using or have used within the past year IV drugs (except for therapeutic use).
  • Are pregnant.
Show all 23Show fewer
  • Have serious liver, kidney, or blood problems.
  • Have had antibiotic therapy in the 14 days before study start.
  • Have taken part in other microbicide or contraceptive studies within 1 month of study start.
  • Have been previously enrolled in this study.
  • Have any genital abnormalities.
  • Are sensitive or allergic to any substances used in the study.
  • Are unwilling to use 1 of the following methods of contraception during the study unless surgically sterilized: non N-9 condoms, hormonal contraceptives, abstinence.
  • Have used any spermicide or condoms that have spermicide on them within 1 week before study start.
  • Have used a hormonal contraceptive method for less than 3 months before study start.
  • Have had any of the following in the 3 months before study start: vaginal bleeding during or following vaginal intercourse; breakthrough menstrual bleeding; an IUD; an abnormal Pap smear; a pregnancy; an abortion; or gynecologic surgery.
  • Have had, in the 6 months before study start, an STD or treatment for any STD, signs of an STD, or signs of genital tract infection.
  • Have any other condition that, in the opinion of the doctor, would be unsafe for the participant or would interfere with the study.
  • Male sexual partners may not be eligible for this study if they have:
  • Been treated for STDs or presumed STDs within 6 months before study start.
  • Symptoms of STDs that cannot be evaluated within 2 weeks of study start.
  • Sensitivity or allergy to any substance used in the study.
  • Any other condition that, in the opinion of the doctor, would be unsafe for the participant or would interfere with the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Harlem Prevention Ctr. CRS (El-Sadr CTU)

    New York, New York, 10037

  • 3535 Market Street CRS

    Philadelphia, Pennsylvania, 19104

  • The Miriam Hosp., Div. of Infectious Disease

    Providence, Rhode Island, 02906

  • Women & Infants' Hosp.

    Providence, Rhode Island, 02906

  • Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)

    The Bronx, New York, 10457

Other trials in United States

About this study

Official title: Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel

The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected and HIV-uninfected women.

The majority of new HIV infections occur through heterosexual contact. A product that stops or slows the replication of HIV during sexual contact is needed. At present, there are no products that are completely effective. PMPA gel, also known as tenofovir, is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases (STDs). It is applied to the vagina and gives women the ability to control their disease-prevention activity.

Read the detailed description

The majority of new HIV infections are transmitted through heterosexual contact. Currently, there is no single product that is completely efficacious in preventing initial HIV infection through vaginal transmission. Thus, the development of a topical product which could block local virus replication once infection has occurred is needed. Topical microbicides are designed to prevent the sexual transmission of HIV and other disease pathogens. Potentially, they can be applied vaginally to prevent both male-to-female and female-to-male transmission. They also offer a female-controlled option. PMPA gel has shown some activity against HIV and STD pathogens in in vitro and in vivo laboratory studies.

Participants undergo eligibility screening tests which include: a general physical exam; a pelvic exam; a urine pregnancy test; urinalysis; HIV and STD testing and counseling; and hematology, liver, and renal function tests. For HIV-infected participants, a CD4 cell count is performed and specimens are collected for quantitation of HIV viral load in plasma and cervico-vaginal fluids. [AS PER AMENDMENT 05/29/02: and for HIV resistance genotyping.] PMPA gel is evaluated among 4 types of women distributed into 7 cohorts. All participants apply PMPA gel intravaginally for 14 consecutive intramenstrual days. The dose and frequency of application is escalated across "cohorts." Cohorts A1 through A4 consist of HIV-uninfected, abstinent women who use different doses of PMPA gel once or twice daily. Cohort B includes HIV-uninfected women who are sexually active. Cohorts C and D consist of HIV-infected women who are abstinent or sexually active, respectively. Cohorts B, C, and D use the highest practical dose frequency. The male partners of sexually active participants undergo HIV and STD testing and counseling as well as an optional genital exam and a post-regimen interview. Participants keep a daily record of when doses are taken and of any adverse effects. Pelvic exams, and hematology, liver, and renal function tests (and CD4 cell counts [AS PER AMENDMENT 05/29/02: and resistance genotyping] in HIV-infected participants) are performed at follow-up visits. After the regimen is complete, participants participate in group interviews to discuss adverse effects, adherence to, and general perception of PMPA gel.

The first 6 participants in Cohorts A2, B, and C take part in a pharmacokinetic (PK) study of PMPA gel. Serum collection and PK analysis are performed at different time intervals during 2 study visits.

Conditions
HIV Infections
Being tested
Tenofovir
Keywords
Risk Factors, Mucous Membrane, Anti-Infective Agents, Cervix Uteri, Vagina, Anti-HIV Agents, Pharmacokinetics, Vulva, 9-(2-phosphonylmethoxypropyl)adenine, HIV Seronegativity
Medical subject headings
HIV Infections

What participants receive

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

  • TenofovirDrug

Timeline

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

  1. First posted14 Dec 2001 (estimated)
  2. Study completionDec 2005

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
Intervention model
Parallel groups
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028132
Sponsor's protocol ID
HPTN 050
Other IDs
10696
Status last verified
Oct 2021
First submitted
13 Dec 2001
Last updated
1 Nov 2021
Results posted
No

Publications

  • Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.

    PubMed 16470118

  • Carballo-Dieguez A, Balan IC, Morrow K, Rosen R, Mantell JE, Gai F, Hoffman S, Maslankowski L, El-Sadr W, Mayer K. Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a Phase I clinical trial (HPTN 050). AIDS Care. 2007 Sep;19(8):1026-31. doi: 10.1080/09540120701294237.

    PubMed 17852000

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tenofovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites 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 22 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 NCT00028132, which also lists 2 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 1 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in