Rectal MicrobicidesPhase 1NCT01232803
Rectal Safety and Acceptability Study of Tenofovir 1% Gel
A Phase 1 study testing Tenofovir 1% gel and 2% N-9 gel in people with Rectal Microbicides, run by CONRAD at 3 sites in United States.
Trial summary
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rectal Microbicides
- What is being tested?
- Tenofovir 1% gel and 2% N-9 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Jul 2011
- 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 of 18 at screening, verified per site SOP
- Willing and able to provide written informed consent for screening and enrollment
- HIV-1 uninfected at screening
- Willing and able to communicate in English
- Willing and able to provide adequate locator information, as defined in site SOP
- Availability to return for all study visits, barring unforeseen circumstances
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- Per participant report at screening, a history of consensual receptive anal intercourse (RAI) at least once in the prior year (Required to assure that participants have a context for the acceptability assessments).
- Willing to abstain from insertion of anything rectally, including sex toys, other than the study gel for the duration of study participation
- Willing to abstain from RAI for the duration of study participation
- Must agree to use study provided condoms for the duration of the study for vaginal and insertive anal intercourse
- Must be in general good health
- At Screening and Enrollment, must agree not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed) In addition to the criteria listed above, female participants must meet the following criteria:
- Postmenopausal or using (or willing to use) an acceptable form of contraception (e.g., barrier method, intrauterine device (IUD), hormonal contraception, surgical sterilization, or vasectomization of male partner). If the female participant has female partners only, the method of contraception will be noted as a barrier method in the study documentation.
Who cannot join
- Abnormalities of the colorectal mucosa, or significant colorectal symptom(s), which in the opinion of the clinician represents a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition
- At screening: participant-reported symptoms, and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that an HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required Note: In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after screening visit will be allowed
- Anorectal sexually transmitted infections (STI) within six months prior to the Screening Visit
- At screening:
- Positive for hepatitis B surface antigen Hemoglobin < 10.0 g/dL Platelet count less than 100,000/mm3 White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3 For females: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min (140- age in years) x (weight in kg) x (0.85 for female)/72 x (serum creatinine in mg/dL) For males: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL) Serum creatinine > 1.3× the site laboratory upper limit of normal (ULN) Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN
- +1 glucose or +1 protein on urinalysis (UA) History of bleeding problems
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- History of significant gastrointestinal bleeding in the opinion of the investigator
- Allergy to methylparaben, propylparaben, sorbic acid, and components of N-9
- Known HIV-infected partners
- By participant report at enrollment, history of excessive daily alcohol use (as defined by the CDC as heavy drinking consisting of an average consumption of more than 2 drinks per day for men, and more than 1 drink per day for women), frequent binge drinking or illicit drug use that includes any injection drugs, methamphetamines (crystal meth), heroin, or cocaine including crack cocaine, within the past 12 months
- Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation: Heparin, including Lovenox® Warfarin Plavix® (clopidogrel bisulfate) Rectally administered medications (including over-the-counter products) Aspirin Non-steroidal anti-inflammatory drugs (NSAIDS) Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy
- By participant report at screening, use of post-exposure prophylaxis for HIV exposure, systemic immunomodulatory medications, rectally administered medications, rectally administered products (including condoms) containing N-9, or any investigational products within the 4 weeks prior to the Enrollment/Baseline Evaluation Visit and throughout study participation
- History of recurrent urticaria
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria:
- Pregnant at the Enrollment/Baseline Visit
- Breastfeeding at screening or intend to breastfeed during study participation per participant report.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
The Fenway Institute
Boston, Massachusetts, 02115
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally.
After completing screening and baseline evaluation, eligible participants will be randomized to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also include a no treatment arm. There will be 15 participants in each arm.
Participants will return to the clinic, where they will self-administer a single dose of the study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens will be obtained. After a one-week recovery period, participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days. Participants will return to clinic for evaluation and specimen collection after completion of 7 days of daily dosing.
Read the detailed description
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally. This study will also determine whether rectal use of tenofovir 1% gel is associated with rectal mucosal damage using a broad range of immunological safety biomarkers, utilizing N-9 as a positive control, as rectal application of N-9 is known to cause mild but transient mucosal damage. Other secondary objectives include evaluations of the acceptability of rectal administration of tenofovir 1% gel as well as the safety of hydroxyethylcellulose (HEC) placebo gel when applied rectally.
Participants will be randomized to receive a single dose of tenofovir 1% gel, 2% N-9 gel or a placebo gel that is applied by a clinician at the study site. The study will also include a no treatment arm. There will be 15 participants in each arm. Participants will return to the clinic, where they will self-administer a single dose of the study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens will be obtained. After a one-week recovery period, participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days. Participants will return to the clinic for evaluation and specimen collection after completion of 7 days of daily dosing.
Receptive anal intercourse is common among men who have sex with men and there is increasing evidence that heterosexual women in the developed and developing world also practice anal sex. It can therefore be anticipated that once vaginal microbicides are licensed, they will be used in both the vaginal and rectal compartments. As a consequence, there is a need to evaluate both the rectal and vaginal safety profile of candidate microbicides. The Rectal Microbicide Program clinical protocols have therefore been developed to assess the safety and pharmacology of tenofovir 1% gel when used rectally in men and women as well as address critical questions regarding rectal microbicides through exploratory objectives.
- Conditions
- Rectal Microbicides
- Being tested
- Tenofovir 1% gel, 2% N-9 gel, HEC Placebo gel
- Keywords
- Rectal Microbicides, Tenofovir, Rectal use, Rectal mucosal damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir 1% gelDrug
Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
2% N-9 gelDrug
Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
HEC Placebo gelDrug
Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
| Study group | Role | What they receive |
|---|---|---|
| 2% N-9 gel | Active comparator | Rectal application of 2% N-9 gel Receives: Drug: 2% N-9 gel |
| HEC placebo gel | Placebo comparator | Rectal application of HEC placebo gel Receives: Drug: HEC Placebo gel |
| no-treatment arm | No intervention | no intervention |
| Tenofovir 1% gel | Experimental | rectal application of Tenofovir 1% gel Receives: Drug: Tenofovir 1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of tenofovir 1% gel when applied rectally
Grade 2 or higher AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009) and/or Addenda 1 and 3 (Female Genital and Rectal Grading Tables for Use in Microbicide Studies)
Measured: Duration of Study
Secondary outcomes (4)
To evaluate the acceptability of tenofovir 1% gel when applied rectally
The proportion of participants who at their Final Clinic Visit report via the acceptability questionnaire that they would be very likely to use the candidate microbicide during receptive anal intercourse
Measured: Duration of Study
To evaluate the safety of the placebo gel when applied rectally
Grade 2 or higher adverse events in the placebo gel arm, as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August MTN-007, Version 2.0 xii August 13, 2010 2009) and/or Addenda 1 and 3 (Female Genital and Rectal Grading Tables for Use in Microbicide Studies)
Measured: Duration of Study
To determine whether use of tenofovir 1% gel is associated with rectal mucosal damage
Changes in the following parameters:
- Epithelial sloughing
- Intestinal histopathology
- Intestinal mucosal mononuclear cell phenotype
- Intestinal mucosal cytokine messenger RNA (mRNA)
- Intestinal mucosal gene expression arrays
- Cytokine profile in rectal secretions
- Fecal calprotectin
- Microflora
Measured: Duration of Study
To determine whether use of 2% nonoxynol-9 gel (Gynol-II®) is associated with rectal mucosal damage
Changes in the following parameters:
- Epithelial sloughing
- Intestinal histopathology
- Intestinal mucosal mononuclear cell phenotype
- Intestinal mucosal cytokine messenger RNA (mRNA)
- Intestinal mucosal gene expression arrays
- Cytokine profile in rectal secretions
- Fecal calprotectin
- Microflora
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal MicrobicidesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232803
- Sponsor's protocol ID
- MTN-007
- Other IDs
- 5U01AI068633-05
- Status last verified
- Jun 2021
- First submitted
- 1 Nov 2010
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, Carballo-Dieguez A, Ayudhya RK, Piper J, Hladik F, Mayer K. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007). PLoS One. 2013;8(4):e60147. doi: 10.1371/journal.pone.0060147. Epub 2013 Apr 3.
PubMed 23573238Leu CS, Mabragana M, Giguere R, Dolezal C, Carballo-Dieguez A, McGowan I. Use of a novel technology to track adherence to product use in a microbicide trial of short duration (MTN-007). AIDS Behav. 2013 Nov;17(9):3101-7. doi: 10.1007/s10461-013-0549-2.
PubMed 23842718Hladik F, Burgener A, Ballweber L, Gottardo R, Vojtech L, Fourati S, Dai JY, Cameron MJ, Strobl J, Hughes SM, Hoesley C, Andrew P, Johnson S, Piper J, Friend DR, Ball TB, Cranston RD, Mayer KH, McElrath MJ, McGowan I. Mucosal effects of tenofovir 1% gel. Elife. 2015 Feb 3;4:e04525. doi: 10.7554/eLife.04525.
PubMed 25647729Hughes SM, Calienes FL, Levy CN, Pandey U, Gornalusse GG, Cranston RD, Lama JR, Pickett J, Brand RM, Hendrix CW, Marzinke MA, Dai JY, Balar B, Justman JE, Nair G, Berard AR, Birse K, Noel-Romas L, Mayer KH, Stekler JD, Mackelprang R, Burgener AD, McGowan I, Cameron CM, Cameron MJ, Woodrow KA, Hladik F. Mucosal tenofovir 1% gel stimulates cell proliferation and type I/III interferon pathways. Microbiol Spectr. 2026 Mar 23;14(5):e0168025. doi: 10.1128/spectrum.01680-25. Online ahead of print.
PubMed 41869811
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel
- ClinicalTrials.gov ID
- NCT01232803
- Acronym / sponsor ID
- MTN-007
- Conditions
- Rectal Microbicides
- Keywords
- Rectal Microbicides, Tenofovir, Rectal use, Rectal mucosal damage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Nov 2010 (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.
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally.
After completing screening and baseline evaluation, eligible participants will be randomized to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also include a no treatment arm. There will be 15 participants in each arm.
Participants will return to the clinic, where they will self-administer a single dose of the study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens will be obtained. After a one-week recovery period, participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days. Participants will return to clinic for evaluation and specimen collection after completion of 7 days of daily dosing.
Detailed description
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally. This study will also determine whether rectal use of tenofovir 1% gel is associated with rectal mucosal damage using a broad range of immunological safety biomarkers, utilizing N-9 as a positive control, as rectal application of N-9 is known to cause mild but transient mucosal damage. Other secondary objectives include evaluations of the acceptability of rectal administration of tenofovir 1% gel as well as the safety of hydroxyethylcellulose (HEC) placebo gel when applied rectally.
Participants will be randomized to receive a single dose of tenofovir 1% gel, 2% N-9 gel or a placebo gel that is applied by a clinician at the study site. The study will also include a no treatment arm. There will be 15 participants in each arm. Participants will return to the clinic, where they will self-administer a single dose of the study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens will be obtained. After a one-week recovery period, participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days. Participants will return to the clinic for evaluation and specimen collection after completion of 7 days of daily dosing.
Receptive anal intercourse is common among men who have sex with men and there is increasing evidence that heterosexual women in the developed and developing world also practice anal sex. It can therefore be anticipated that once vaginal microbicides are licensed, they will be used in both the vaginal and rectal compartments. As a consequence, there is a need to evaluate both the rectal and vaginal safety profile of candidate microbicides. The Rectal Microbicide Program clinical protocols have therefore been developed to assess the safety and pharmacology of tenofovir 1% gel when used rectally in men and women as well as address critical questions regarding rectal microbicides through exploratory objectives.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2% N-9 gel | Active comparator | Drug: 2% N-9 gelRectal application of 2% N-9 gel |
| HEC placebo gel | Placebo comparator | Drug: HEC Placebo gelRectal application of HEC placebo gel |
| no-treatment arm | No intervention | –no intervention |
| Tenofovir 1% gel | Experimental | Drug: Tenofovir 1% gelrectal application of Tenofovir 1% gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥ Age of 18 at screening, verified per site SOP
- Willing and able to provide written informed consent for screening and enrollment
- HIV-1 uninfected at screening
- Willing and able to communicate in English
- Willing and able to provide adequate locator information, as defined in site SOP
Key exclusion criteria (16 listed)
- Abnormalities of the colorectal mucosa, or significant colorectal symptom(s), which in the opinion of the clinician represents a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition
- At screening: participant-reported symptoms, and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that an HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required Note: In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after screening visit will be allowed
- Anorectal sexually transmitted infections (STI) within six months prior to the Screening Visit
- At screening:
- Positive for hepatitis B surface antigen Hemoglobin < 10.0 g/dL Platelet count less than 100,000/mm3 White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3 For females: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min (140- age in years) x (weight in kg) x (0.85 for female)/72 x (serum creatinine in mg/dL) For males: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL) Serum creatinine > 1.3× the site laboratory upper limit of normal (ULN) Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN
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 1% gelEntire contents of an applicator will be inserted rectally, for a total of 8 doses. | Drug | Tenofovir 1% gel |
| 2% N-9 gelEntire contents of an applicator will be inserted rectally, for a total of 8 doses. | Drug | 2% N-9 gel |
| HEC Placebo gelEntire contents of an applicator will be inserted rectally, for a total of 8 doses. | Drug | HEC placebo gel |
Primary outcome
To evaluate the safety of tenofovir 1% gel when applied rectally
Time frame: Duration of Study
Grade 2 or higher AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009) and/or Addenda 1 and 3 (Female Genital and Rectal Grading Tables for Use in Microbicide Studies)
4 secondary outcomes
To evaluate the acceptability of tenofovir 1% gel when applied rectally
Time frame: Duration of Study
To evaluate the safety of the placebo gel when applied rectally
Time frame: Duration of Study
To determine whether use of tenofovir 1% gel is associated with rectal mucosal damage
Time frame: Duration of Study
To determine whether use of 2% nonoxynol-9 gel (Gynol-II®) is associated with rectal mucosal damage
Time frame: Duration of Study
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 28 Jun 2021.
- Results publication: PubMed 23573238McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, Carballo-Dieguez A, Ayudhya RK, Piper J, Hladik F, Mayer K. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007). PLoS One. 2013;8(4):e60147. doi: 10.1371/journal.pone.0060147. Epub 2013 Apr 3.
- Results publication: PubMed 23842718Leu CS, Mabragana M, Giguere R, Dolezal C, Carballo-Dieguez A, McGowan I. Use of a novel technology to track adherence to product use in a microbicide trial of short duration (MTN-007). AIDS Behav. 2013 Nov;17(9):3101-7. doi: 10.1007/s10461-013-0549-2.
- Results publication: PubMed 25647729Hladik F, Burgener A, Ballweber L, Gottardo R, Vojtech L, Fourati S, Dai JY, Cameron MJ, Strobl J, Hughes SM, Hoesley C, Andrew P, Johnson S, Piper J, Friend DR, Ball TB, Cranston RD, Mayer KH, McElrath MJ, McGowan I. Mucosal effects of tenofovir 1% gel. Elife. 2015 Feb 3;4:e04525. doi: 10.7554/eLife.04525.
- Derived from this study: PubMed 41869811Hughes SM, Calienes FL, Levy CN, Pandey U, Gornalusse GG, Cranston RD, Lama JR, Pickett J, Brand RM, Hendrix CW, Marzinke MA, Dai JY, Balar B, Justman JE, Nair G, Berard AR, Birse K, Noel-Romas L, Mayer KH, Stekler JD, Mackelprang R, Burgener AD, McGowan I, Cameron CM, Cameron MJ, Woodrow KA, Hladik F. Mucosal tenofovir 1% gel stimulates cell proliferation and type I/III interferon pathways. Microbiol Spectr. 2026 Mar 23;14(5):e0168025. doi: 10.1128/spectrum.01680-25. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 1% gel and 2% N-9 gel in people with Rectal Microbicides, run by CONRAD at 3 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 13 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 28 Jun 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. 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?
To evaluate the safety of tenofovir 1% gel when applied rectally (time frame: Duration of Study). 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 NCT01232803, which also lists 4 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 28 Jun 2021.