High Risk MSMPhase 1Project GelNCT01283360
Microbicide Safety and Acceptability in Young Men
A Phase 1 study testing Tenofovir 1% Gel in people with High Risk MSM and HIV Negative, run by CONRAD at 3 sites in 2 countries.
Trial summary
After completing a screening evaluation, 280 eligible participants, including 40 sex workers, will be enrolled into Stage 1A of the study during which they will undergo a baseline medical evaluation for both history and presence of STIs and anorectal health pathologies or injuries, as well as a detailed Web-based… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk MSM, HIV Negative, 18-30 Years of Age
- What is being tested?
- Tenofovir 1% Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2010to May 2013
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completed study stage 1AB
- HIV-1 uninfected at screening based on HIV rapid test results
- Availability to return for all Stage 2 visits, barring unforeseen circumstances
- Exclusion Criteria for Participants in Stage 1A (both sex workers and non sex-workers):
- 1. Any condition or prior therapy that, in the opinion of the investigator, would 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
- Exclusion Criteria for Participants in Stage 1B (both sex workers and non sex-workers):
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- Clinical or laboratory diagnosis of active rectal infection requiring treatment per current CDC guidelines. Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and if clinically indicated, genital warts. Note that an HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required
- Positive Hepatitis B surface antigen test indicating hepatitis B infection
- Allergy to methylparaben, propylparaben, or latex
- History of significant drug allergy or recurrent urticaria
- History of inflammatory bowel disease
- Currently engage or plan to engage in unprotected RAI with HIV-infected partners
- By participant report planning to receive another investigational drug while participating in this study
- Any other condition or prior therapy that, in the opinion of the investigator, would 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
Who cannot join
- Meet any of the exclusion criteria for Stage 1B
- Reporting a history of transactional sex (i.e., having received money or other goods/services in exchange for sex) in the prior 6 months
- Undergoing or completed gender reassignment
- Grade 2 or higher liver function, creatinine, coagulation, electrolyte, or hematology abnormality in accordance with DAIDS toxicity table values (normal values based on site specific laboratory criteria) at screening (or Visit 2 PT/INR for coagulation), and confirmed by retest/and or redraw
- History of significant gastrointestinal bleeding
- History of inflammatory bowel disease
Show all 17Show fewer
- Abnormalities of the rectal mucosa, or significant rectal 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 of the local mucosa, and presence of symptomatic external hemorrhoids
- Per participant report, anticipated use and/or unwillingness to abstain from the following medications during the period of Stage 2 study participation:
- Heparin, including Lovenox®
- Warfarin
- Plavix® (clopidogrel bisulfate)
- Aspirin >81 mg per day
- Non-steroidal anti-inflammatory drugs (NSAIDS)
- Any other drugs that are associated with increased likelihood of bleeding following rectal biopsy
- By participant report, use of systemic immunomodulatory medications within the 4 weeks prior to the Stage 2 Enrollment Visit and throughout study participation
- By participant report, use of rectally administered medications, rectally administered products (including condoms) containing N-9, or any investigational products within the 2 weeks or 10 half-lives of the drug, whichever is longer, prior to the Stage 2 Enrollment Visit, or is planning to receive another investigational drug while participating in this study
- Any other condition or prior therapy that, in the opinion of the investigator, would 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 -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The Fenway Institute-Fenway Community Health
Boston, Massachusetts, 02215
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Puerto Rico1 site
University of Puerto Rico Medical Sciences Campus
San Juan, 00936
About this study
After completing a screening evaluation, 280 eligible participants, including 40 sex workers, will be enrolled into Stage 1A of the study during which they will undergo a baseline medical evaluation for both history and presence of STIs and anorectal health pathologies or injuries, as well as a detailed Web-based baseline behavioral assessment. The first 140 eligible participants, including 20 sex workers, reporting at least one occasion of unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In Stage 1B participants will apply the universal placebo gel (HEC) rectally prior to each episode of RAI over a 3-month period, reporting each use via a phone reporting system; they will complete a Web-based questionnaire and take part in a video teleconference at the end of the 3 months. The first 24 eligible participants completing Stage 1B will be invited to enroll in Stage 2. The subset of sex workers who took part in Stages 1A and 1B will terminate participation at the end of 1B. Eligible participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel as part of Stage 2, the Phase 1 safety study. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection.
Read the detailed description
Microbicides are products that can be applied in the vagina or rectum to decrease the chances of transmission of sexually transmitted infections (STIs) including HIV. In the US, one of the most vulnerable groups for acquiring HIV infection is young men, especially young Black and Latino men who have sex with men (MSM). This study will be conducted with a young 18-30 year-old ethnically diverse sample of HIV-negative MSM who report engaging in receptive anal intercourse (RAI) using condoms inconsistently or not at all. Our goal is to test whether patterns of use of a placebo rectal gel prior to RAI suggest that the product would be used correctly and consistently in real life circumstances and whether this highly vulnerable population could safely use tenofovir gel, a microbicide candidate. In Version 3.0 of this multicentered protocol, a cohort of 40 male and transgender female sex workers were added to Stages 1A and 1B in order to determine the feasibility of recruitment and retention of men who have sex with men (MSM) with high risk sexual behavior, such as sex workers, for microbicide studies, and their likelihood to use noncondom based HIV prevention strategies. This study will be conducted by the University of Pittsburgh in collaboration with researchers at the HIV Center for Clinical and BehavioralStudies at Columbia University; the Fenway Community Health in Boston; and the University of Puerto Rico Clinical Trial Unit in San Juan, Puerto Rico. Subjects will be enrolled at the University of Pittsburgh, Fenway Community Health, and the University of Puerto Rico. This is a two-stage longitudinal study including a clinical and behavioral evaluation (Stage 1A) with an acceptability and adherence trial (Stage 1B), followed by a Phase 1 randomized, double-blind, multi-site, placebo-controlled trial (Stage 2). Participants who complete Stage 1A are eligible to be selected for enrollment into Stage 1B; a similar transition occurs between Stage 1B and Stage 2.
- In Stage 1A, approximately 280 MSM between the ages of 18-30 will be enrolled, including a subset of 40 sex workers and will undergo a baseline medical evaluation and a detailed Web-based baseline behavioral assessment.
- In Stage 1B, approximately 140 participants from Satge 1A, including a subset of 20 sex workers, will be asked to apply a placebo gel (HEC) rectally prior to each episode of RAI over a 3-month period, reporting each use via a phone reporting system. At the end of the 3 months, participants will complete a Web-based questionnaire and take part in a video teleconference.The first 42 eligible participants, excluding the mal and transgender female sex worker cohort, (approximately 14 at each site) completing Stage 1B with a reported adherence of 80% or greater will be invited to enroll in Stage 2.
- In Stage 2, approximately 24 eligible participants from Stage 1B will progress to Stage 2 and be randomized at a 1:1 ratio to tenofovir 1% gel or HEC placebo gel.Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection.
- Conditions
- High Risk MSM, HIV Negative, 18-30 Years of Age
- Being tested
- HEC Placebo Gel, Tenofovir 1% Gel
- Keywords
- MSM, HIV negative, microbicide, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC Placebo GelOther
The HEC universal placebo gel for Stage 2 will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the HEC placebo gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators with HEC placebo gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of HEC gel.
Tenofovir 1% GelDrug
Tenofovir 1% gel will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the tenofovir 1% gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators designed for vaginal use with tenofovir 1% gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of tenofovir 1% gel (equal to 4.4 g).
| Study group | Role | What they receive |
|---|---|---|
| HEC Placebo Gel | Placebo comparator | In Stage 2, participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection. Receives: Other: HEC Placebo Gel |
| Tenofovir 1% Gel | Active comparator | In Stage 2, participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection. Receives: Drug: Tenofovir 1% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1AB Primary behavioral outcomes
- Identification of factors related to acceptability and adherence
- Proportion of participants who report via the acceptability questionnaire that they would be very likely to use a similar candidate microbicide gel during receptive anal intercourse (RAI)
- Proportion of RAI episodes in which the gel was used
- Comparison between self-reports of placebo gel use and applicator counts in Stage 1B
Measured: 3 months
Stage 1AB Primary clinical outcome
the presence of STIs and anal and rectal pathologies as detected by standard anoscopy
Measured: 3 months
Stage 2 Primary clinical outcomes
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, Dec 2004 and/or Addenda 3 (Rectal Grading Tables for Use in Microbicide Studies).
Measured: 6 months
Stage 2 Behavioral
- Identification of factors related to acceptability and adherence
- Proportion of participants who report via the acceptability questionnaire that they would be very likely to use a similar candidate microbicide gel during receptive anal intercourse (RAI)
- Proportion of RAI episodes in which the gel was used by participants
- Comparison between self-reports of gel use and applicator counts
Measured: 6 months
Secondary outcomes (4)
Stage 1AB Secondary clinical endpoint
Percent of agreement between reports of anal and rectal pathologies by two assessment methods (standard anoscopy versus high-resolutions anoscopy).
Measured: 3 months
Stage 2 Secondary behavioral outcomes
- Identification of factors related to sexual behaviors (e.g., douching, lubricant use, recreational drug use, condom use, partner selection)
- Prevalence of risky sexual practices, douching, lubricant use, recreational drug use, and condom use
Measured: 6 months
Stage 1AB Secondary behavioral outcomes
- Identification of factors related to sexual behaviors (e.g., condom use, lubricant use, douching, risky sexual practices, and recreational drug use)
- Prevalence of condom use, lubricant use, douching, risky sexual practices, and recreational drug use
Measured: 3 months
Stage 2 Behavioral
- Identification of factors related to sexual behaviors (e.g., douching, lubricant use, recreational drug use, condom use, partner selection)
- Prevalence of risky sexual practices, douching, lubricant use, recreational drug use, and condom use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2013
- Study completionMay 2013
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 High Risk MSMStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ian McGowan, MD, PhD, Principal investigator, University of PittsburghAlex Carballo-Dieguez, PhD, Principal investigator, New York State Psychiatric Institute and Columbia UniversityLynne M. Mofensen, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283360
- Sponsor's protocol ID
- 1009001
- Other IDs
- Grant #:1R01HD059533-01A1
- Acronym
- Project Gel
- Status last verified
- May 2015
- First submitted
- 24 Jan 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McGowan I, Cranston RD, Mayer KH, Febo I, Duffill K, Siegel A, Engstrom JC, Nikiforov A, Park SY, Brand RM, Jacobson C, Giguere R, Dolezal C, Frasca T, Leu CS, Schwartz JL, Carballo-Dieguez A. Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women. PLoS One. 2016 Jun 30;11(6):e0158310. doi: 10.1371/journal.pone.0158310. eCollection 2016.
PubMed 27362788
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbicide Safety and Acceptability in Young Men
- ClinicalTrials.gov ID
- NCT01283360
- Acronym / sponsor ID
- Project Gel / 1009001
- Conditions
- High Risk MSM, HIV Negative, 18-30 Years of Age
- Keywords
- MSM, HIV negative, microbicide, prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- Oct 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Jan 2011 (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.
After completing a screening evaluation, 280 eligible participants, including 40 sex workers, will be enrolled into Stage 1A of the study during which they will undergo a baseline medical evaluation for both history and presence of STIs and anorectal health pathologies or injuries, as well as a detailed Web-based baseline behavioral assessment. The first 140 eligible participants, including 20 sex workers, reporting at least one occasion of unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In Stage 1B participants will apply the universal placebo gel (HEC) rectally prior to each episode of RAI over a 3-month period, reporting each use via a phone reporting system; they will complete a Web-based questionnaire and take part in a video teleconference at the end of the 3 months. The first 24 eligible participants completing Stage 1B will be invited to enroll in Stage 2. The subset of sex workers who took part in Stages 1A and 1B will terminate participation at the end of 1B. Eligible participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel as part of Stage 2, the Phase 1 safety study. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection.
Detailed description
Microbicides are products that can be applied in the vagina or rectum to decrease the chances of transmission of sexually transmitted infections (STIs) including HIV. In the US, one of the most vulnerable groups for acquiring HIV infection is young men, especially young Black and Latino men who have sex with men (MSM). This study will be conducted with a young 18-30 year-old ethnically diverse sample of HIV-negative MSM who report engaging in receptive anal intercourse (RAI) using condoms inconsistently or not at all. Our goal is to test whether patterns of use of a placebo rectal gel prior to RAI suggest that the product would be used correctly and consistently in real life circumstances and whether this highly vulnerable population could safely use tenofovir gel, a microbicide candidate. In Version 3.0 of this multicentered protocol, a cohort of 40 male and transgender female sex workers were added to Stages 1A and 1B in order to determine the feasibility of recruitment and retention of men who have sex with men (MSM) with high risk sexual behavior, such as sex workers, for microbicide studies, and their likelihood to use noncondom based HIV prevention strategies. This study will be conducted by the University of Pittsburgh in collaboration with researchers at the HIV Center for Clinical and BehavioralStudies at Columbia University; the Fenway Community Health in Boston; and the University of Puerto Rico Clinical Trial Unit in San Juan, Puerto Rico. Subjects will be enrolled at the University of Pittsburgh, Fenway Community Health, and the University of Puerto Rico. This is a two-stage longitudinal study including a clinical and behavioral evaluation (Stage 1A) with an acceptability and adherence trial (Stage 1B), followed by a Phase 1 randomized, double-blind, multi-site, placebo-controlled trial (Stage 2). Participants who complete Stage 1A are eligible to be selected for enrollment into Stage 1B; a similar transition occurs between Stage 1B and Stage 2.
- In Stage 1A, approximately 280 MSM between the ages of 18-30 will be enrolled, including a subset of 40 sex workers and will undergo a baseline medical evaluation and a detailed Web-based baseline behavioral assessment.
- In Stage 1B, approximately 140 participants from Satge 1A, including a subset of 20 sex workers, will be asked to apply a placebo gel (HEC) rectally prior to each episode of RAI over a 3-month period, reporting each use via a phone reporting system. At the end of the 3 months, participants will complete a Web-based questionnaire and take part in a video teleconference.The first 42 eligible participants, excluding the mal and transgender female sex worker cohort, (approximately 14 at each site) completing Stage 1B with a reported adherence of 80% or greater will be invited to enroll in Stage 2.
- In Stage 2, approximately 24 eligible participants from Stage 1B will progress to Stage 2 and be randomized at a 1:1 ratio to tenofovir 1% gel or HEC placebo gel.Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEC Placebo Gel | Placebo comparator | Other: HEC Placebo GelIn Stage 2, participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection. |
| Tenofovir 1% Gel | Active comparator | Drug: Tenofovir 1% GelIn Stage 2, participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab, stool, and rectal biopsy specimens will be obtained via anoscopy. 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, after which they will return to the clinic for evaluation and specimen collection. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Completed study stage 1AB
- HIV-1 uninfected at screening based on HIV rapid test results
- Availability to return for all Stage 2 visits, barring unforeseen circumstances
- 1. Any condition or prior therapy that, in the opinion of the investigator, would 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
- Clinical or laboratory diagnosis of active rectal infection requiring treatment per current CDC guidelines. Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and if clinically indicated, genital warts. Note that an HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required
Key exclusion criteria (17 listed)
- Meet any of the exclusion criteria for Stage 1B
- Reporting a history of transactional sex (i.e., having received money or other goods/services in exchange for sex) in the prior 6 months
- Undergoing or completed gender reassignment
- Grade 2 or higher liver function, creatinine, coagulation, electrolyte, or hematology abnormality in accordance with DAIDS toxicity table values (normal values based on site specific laboratory criteria) at screening (or Visit 2 PT/INR for coagulation), and confirmed by retest/and or redraw
- History of significant gastrointestinal bleeding
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 |
|---|---|---|
| HEC Placebo GelThe HEC universal placebo gel for Stage 2 will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the HEC placebo gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators with HEC placebo gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of HEC gel. | Other | HEC Placebo Gel |
| Tenofovir 1% GelTenofovir 1% gel will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the tenofovir 1% gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators designed for vaginal use with tenofovir 1% gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of tenofovir 1% gel (equal to 4.4 g). | Drug | Tenofovir 1% Gel |
Primary outcome
Stage 1AB Primary behavioral outcomes
Time frame: 3 months
* Identification of factors related to acceptability and adherence * Proportion of participants who report via the acceptability questionnaire that they would be very likely to use a similar candidate microbicide gel during receptive anal intercourse (RAI) * Proportion of RAI episodes in which the gel was used * Comparison between self-reports of placebo gel use and applicator counts in Stage 1B
Stage 1AB Primary clinical outcome
Time frame: 3 months
the presence of STIs and anal and rectal pathologies as detected by standard anoscopy
Stage 2 Primary clinical outcomes
Time frame: 6 months
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, Dec 2004 and/or Addenda 3 (Rectal Grading Tables for Use in Microbicide Studies).
Stage 2 Behavioral
Time frame: 6 months
* Identification of factors related to acceptability and adherence * Proportion of participants who report via the acceptability questionnaire that they would be very likely to use a similar candidate microbicide gel during receptive anal intercourse (RAI) * Proportion of RAI episodes in which the gel was used by participants * Comparison between self-reports of gel use and applicator counts
4 secondary outcomes
Stage 1AB Secondary clinical endpoint
Time frame: 3 months
Stage 2 Secondary behavioral outcomes
Time frame: 6 months
Stage 1AB Secondary behavioral outcomes
Time frame: 3 months
Stage 2 Behavioral
Time frame: 6 months
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 May 2015.
- Derived from this study: PubMed 27362788McGowan I, Cranston RD, Mayer KH, Febo I, Duffill K, Siegel A, Engstrom JC, Nikiforov A, Park SY, Brand RM, Jacobson C, Giguere R, Dolezal C, Frasca T, Leu CS, Schwartz JL, Carballo-Dieguez A. Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women. PLoS One. 2016 Jun 30;11(6):e0158310. doi: 10.1371/journal.pone.0158310. eCollection 2016.
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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.
Ian McGowan, MD, PhD principal investigator
University of Pittsburgh
Alex Carballo-Dieguez, PhD principal investigator
New York State Psychiatric Institute and Columbia University
Lynne M. Mofensen, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir 1% Gel in people with High Risk MSM and HIV Negative, run by CONRAD 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 14 inclusion and 17 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 May 2015. 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, Puerto Rico. 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?
Stage 1AB Primary behavioral outcomes (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT01283360, 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 28 May 2015.