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HIV InfectionsPhase 2NCT00111943

Safety and Acceptability of a Vaginal Microbicide

A Phase 2 study testing 1% tenofovir gel in people with HIV Infections and Hepatitis B, Chronic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.

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

The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women. Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections, Hepatitis B, Chronic
What is being tested?
1% tenofovir gel
How many people
200 participants
Where
3 sitesin 2 countries
Study dates
Start not givento Oct 2007
Phase
Phase 2
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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • HIV uninfected
  • Good general health
  • Sexually active
  • Willing to use acceptable methods of contraception, including male latex condoms for all acts of intercourse
  • Willing to undergo all study-related assessments and adhere to the requirements of the study

Who cannot join

  • Menopausal or postmenopausal
  • Hysterectomy
  • Abnormal screening results for several gynecologic exams
  • Taking or planning to take tenofovir, adefovir, or any other medication for chronic HBV infection
  • History of latex allergy
  • History of adverse reaction to tenofovir or adefovir
Show all 15Show fewer
  • Use of a diaphragm or spermicide for contraception
  • Prior participation in the study
  • Prior participation in any vaginal microbicide, spermicide, or other drug study within 30 days of study entry
  • Gynecologic surgical procedure within 90 days of study entry
  • Illicit injection drug use within 12 months of study entry
  • History of vaginal intercourse more than an average of two times per day in the two weeks prior to study screening
  • Any other criteria that, in the investigator's opinion, may interfere with the study
  • Current pregnancy or previous pregnancy within 90 days of study entry
  • Breastfeeding

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Alabama Microbicide CRS

    Birmingham, Alabama, 35294-0022

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

    The Bronx, New York

Other trials in United States

India1 site

  • NARI Arogya Aadhar Clinic CRS

    Pune, Maharashtra, 411002

Other trials in India

About this study

Official title: Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel

The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women.

Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health.

Read the detailed description

While the male condom is effective in preventing sexual transmission of HIV, its use is hampered by deeply rooted cultural and social barriers. About half of all HIV infections worldwide occur in women, yet the only available female-controlled method of HIV prevention is the female condom. Alternative prevention tools, such as vaginal microbicides, are urgently needed to slow the rapid spread of heterosexual HIV infection.

This study will last 24 weeks, with an additional 10 weeks of follow-up for participants with chronic hepatitis B virus (HBV) infection. Participants will be randomly assigned to one of four arms. Arm A participants will insert a vaginal tenofovir 1% gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm B participants will insert a vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm C participants will insert a vaginal tenofovir 1% gel once daily at bedtime or during the longest period of daily rest. Arm D participants will insert a vaginal placebo gel once daily at bedtime or during the longest period of daily rest.

A medical and menstrual history update, pregnancy test, HIV and sexually transmitted infections (STI) risk reduction counseling, and interview to assess behaviors toward vaginal gel use will occur during all study visits. HIV/STI counseling and testing, urinalysis, and blood collection will occur at study entry and at Week 24. Pelvic exam with colposcopy and vaginal swab collection will occur at study entry and Weeks 4, 12, and 24. For participants with chronic HBV, additional blood will be collected to monitor hepatitis B infection at study entry and Weeks 12, 24, 28, 32, and 36.

Being tested
1% tenofovir gel
Keywords
Anti-Infective Agents, Local, HIV Seronegativity, Tenofovir, Vaginal gel, Microbicide, Vaginal Microbicide, PMPA
Medical subject headings
HIV Infections, Hepatitis B, Chronic

What participants receive

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

  • 1% tenofovir gelDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator

Secondary outcomes (2)

  1. Adherence to the study gel regimen

  2. acceptability of the study gel

Timeline

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

  1. First posted27 May 2005 (estimated)
  2. Study completionOct 2007

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111943
Sponsor's protocol ID
HPTN 059
Other IDs
10145
Status last verified
Oct 2021
First submitted
26 May 2005
Last updated
1 Nov 2021
Results posted
No

Publications

  • Bentley ME, Fullem AM, Tolley EE, Kelly CW, Jogelkar N, Srirak N, Mwafulirwa L, Khumalo-Sakutukwa G, Celentano DD. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004 Jul;94(7):1159-64. doi: 10.2105/ajph.94.7.1159.

    PubMed 15226137

  • D'Cruz OJ, Uckun FM. Clinical development of microbicides for the prevention of HIV infection. Curr Pharm Des. 2004;10(3):315-36. doi: 10.2174/1381612043386374.

    PubMed 14754390

  • Mantell JE, Myer L, Carballo-Dieguez A, Stein Z, Ramjee G, Morar NS, Harrison PF. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005 Jan;60(2):319-30. doi: 10.1016/j.socscimed.2004.05.011.

    PubMed 15522488

  • 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

  • Van Damme L. Clinical microbicide research: an overview. Trop Med Int Health. 2004 Dec;9(12):1290-6. doi: 10.1111/j.1365-3156.2004.01338.x.

    PubMed 15598260

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1% tenofovir gel in people with HIV Infections and Hepatitis B, Chronic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.

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 5 inclusion and 15 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 3 sites in United States, India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111943, 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 1 Nov 2021.

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