HIV InfectionsPhase 1NCT00594373
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
A Phase 1 study testing Tenofovir gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). 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
- What is being tested?
- Tenofovir gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2010
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal menstrual history with regular cycles and with a minimum of 21 days between menses
- Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected
- Agree to abstain from sexual intercourse and to not use vaginal products within 48 hours of study entry and for the duration of the study
Who cannot join
- HIV infected
- Sexually transmitted infection within 6 months of study entry
- Use of nontherapeutic intravenous drugs within 12 months of study entry
- Menopausal
- Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
- Menstruating at screening or enrollment visits
Show all 19Show fewer
- Positive urine culture
- Positive chlamydia, gonorrhea, or trichomonas result at screening
- Abnormal Pap smear
- Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
- History of toxic shock syndrome or a history of symptoms suggesting toxic shock syndrome
- History of intermenstrual bleeding within 3 months of study entry
- Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months of study entry
- Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month of study entry
- Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours of study entry
- Acute or chronic hepatitis B virus infection
- Liver or kidney abnormalities
- Oral antibiotics within 7 days of study entry
- Pregnant, less than 6 months postpartum, or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
The Bronx, New York, 10461
About this study
Official title: Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.
Read the detailed description
A new approach to HIV prevention currently being studied is the use of topical microbicides. This study will measure the mucosal response to daily intravaginal applications of 1% tenofovir gel versus placebo in two groups of women at low risk for HIV infection.
The duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel for 14 consecutive days between menses.
Study visits will occur on Days 3, 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 30 days of screening. Medical and sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits. All participants will be asked to complete a diary throughout the study; this diary will be reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear result within the last year is not available.
- Conditions
- HIV Infections
- Being tested
- Tenofovir gel, Tenofovir gel placebo
- Keywords
- Microbicide, 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.
Tenofovir gelDrug
Also called TFV, 9-(2-[Phosphonomethoxy]propyl)adenine
1 gm/100 ml of 1% tenofovir gel vaginally daily
Tenofovir gel placeboDrug
1 gm/100 ml of placebo gel vaginally daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Application of 1% tenofovir gel for 14 consecutive days between menses Receives: Drug: Tenofovir gel |
| 2 | Placebo comparator | Application of 1% tenofovir placebo gel for 14 consecutive days between menses Receives: Drug: Tenofovir gel placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
Measured: At Days 3, 7, 14, and 21
Secondary outcomes (1)
Changes in antimicrobial activity of cervicovaginal secretions
Measured: At Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marla Keller, MD, Principal investigator, Albert Einstein College of MedicineBetsy Herold, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594373
- Sponsor's protocol ID
- TFV 010
- Other IDs
- 10443, U01AI069551
- Status last verified
- Oct 2021
- First submitted
- 2 Jan 2008
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
PubMed 17805450Mayer 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 16470118Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One. 2011 Jan 25;6(1):e16475. doi: 10.1371/journal.pone.0016475.
PubMed 21283552
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00594373
- Acronym / sponsor ID
- TFV 010
- Conditions
- HIV Infections
- Keywords
- Microbicide, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Jan 2008 (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.
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.
Detailed description
A new approach to HIV prevention currently being studied is the use of topical microbicides. This study will measure the mucosal response to daily intravaginal applications of 1% tenofovir gel versus placebo in two groups of women at low risk for HIV infection.
The duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel for 14 consecutive days between menses.
Study visits will occur on Days 3, 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 30 days of screening. Medical and sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits. All participants will be asked to complete a diary throughout the study; this diary will be reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear result within the last year is not available.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tenofovir gelApplication of 1% tenofovir gel for 14 consecutive days between menses |
| 2 | Placebo comparator | Drug: Tenofovir gel placeboApplication of 1% tenofovir placebo gel for 14 consecutive days between menses |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal menstrual history with regular cycles and with a minimum of 21 days between menses
- Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected
- Agree to abstain from sexual intercourse and to not use vaginal products within 48 hours of study entry and for the duration of the study
Key exclusion criteria (19 listed)
- HIV infected
- Sexually transmitted infection within 6 months of study entry
- Use of nontherapeutic intravenous drugs within 12 months of study entry
- Menopausal
- Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
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 |
|---|---|---|
| Tenofovir gelAlso: TFV, 9-(2-[Phosphonomethoxy]propyl)adenine1 gm/100 ml of 1% tenofovir gel vaginally daily | Drug | 1 |
| Tenofovir gel placebo1 gm/100 ml of placebo gel vaginally daily | Drug | 2 |
Primary outcome
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
Time frame: At Days 3, 7, 14, and 21
1 secondary outcome
Changes in antimicrobial activity of cervicovaginal secretions
Time frame: At Day 14
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 1 Nov 2021.
- Background: PubMed 17805450Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
- Background: PubMed 16470118Mayer 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.
- Derived from this study: PubMed 21283552Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One. 2011 Jan 25;6(1):e16475. doi: 10.1371/journal.pone.0016475.
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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.
Marla Keller, MD principal investigator
Albert Einstein College of Medicine
Betsy Herold, MD principal investigator
Albert Einstein College of Medicine
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 Tenofovir gel 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 3 inclusion and 19 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 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions (time frame: At Days 3, 7, 14, and 21). 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 NCT00594373, which also lists 3 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.