HIV PreventionPhase 1RMP02-MTN006NCT00984971
Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet
A Phase 1 study testing Tenofovir and Open label tenofovir tablet in people with HIV Prevention and HIV Infections, run by CONRAD at 2 sites in United States.
Trial summary
To date, the majority of microbicide research has focused on the assessment of the safety and effectiveness of vaginal microbicides used for the prevention of HIV transmission via the vaginal compartment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Infections
- What is being tested?
- Tenofovir and Open label tenofovir tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ Age of 18 at screening
- Willing and able to provide written informed consent for screening and enrollment
- HIV-1 uninfected at screening according to the standard DAIDS algorithm in Appendix II
- Willing and able to communicate in English
- Willing and able to provide adequate locator information, as defined in site standard operating procedures (SOP)
- Availability to return for all study visits, barring unforeseen circumstances
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- Per participant report at screening, a history of consensual RAI at least once in the prior year
- Willing to abstain from insertion of anything rectally including sex toys, other than the study gel during the active phases of the study and for 5 days following biopsy collection
- Willing to abstain from sexual intercourse (rectal and vaginal) during the active phases of the study and for 5 days following biopsy collection
- 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
- Must agree not to participate in other drug trials
- In addition to the criteria listed above, female participants must meet the following criteria:
- Post-menopausal or using (or willing to use) an acceptable form of contraception (e.g., barrier method, 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 of the local mucosa, and presence of symptomatic external hemorrhoids)
- At screening, clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines or urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that HSV-2 seropositive with no active lesions is allowed, since treatment is not required.
- Note: Allow one re-screening after documented treatment (30 days) in cases of GC/CT identified at screening
- At screening:
- Positive for hepatitis B surface antigen
- Hemoglobin < 10.0 g/dL
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- Platelet count < 100,000/mm3
- White blood cell count less than 2,000 cells/mm3 or > than 15,000 cells/mm3
- Calculated creatinine clearance less than 80 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 females)/72 x (serum creatinine in mg/dL)
- Serum creatinine > 1.3× the site laboratory upper limit of normal (ULN)
- ALT and/or AST > 2.5× the site laboratory ULN
- +1 glucose or +1 protein on urinalysis (UA)
- History of bleeding problems (i.e. INR > 1.5× the site laboratory ULN or PTT > 1.25× the site laboratory ULN)
- History of significant gastrointestinal bleeding in the opinion of the investigator
- Allergy to methylparaben, propylparaben, sorbic acid
- 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
- NSAIDS
- Acyclovir
- Valacyclovir
- TDF
- Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy
- By participant report at screening, use of 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
- 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 Enrollment/Baseline Evaluation Visit
- Breastfeeding or intent to breastfeed during duration of study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Center for HIV Prevention Research
Los Angeles, California, 90024
University of Pittsburgh Clinical Research Unit
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adults
To date, the majority of microbicide research has focused on the assessment of the safety and effectiveness of vaginal microbicides used for the prevention of HIV transmission via the vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with men (MSM), 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. Therefore, the primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally. In addition, this study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK) profiles.
This study was designed to address the following hypotheses:
- Vaginally-formulated tenofovir 1% topical gel when applied rectally will be safe using a combination of clinical and laboratory markers including assays specifically designed to measure mucosal toxicity
- Tenofovir will be detectable at different concentrations in the various anatomic compartments sampled for pharmacokinetics following single and 7-day topical exposures
- Exposure to tenofovir 1% gel will demonstrate prevention of ex vivo HIV-1 challenge using in vivo drug-exposed tissue as compared to baseline tissue samples
- Orally delivered, single dose, 300 mg tenofovir disoproxil fumarate tablets will have similar safety profiles using routine blood safety indices as have been established in other trials and will show no mucosal safety concerns
- The oral dose will have different multi-compartment concentration kinetics than the topical tenofovir and will also demonstrate preliminary (ex vivo) prevention using the explant infectivity assay
- Vaginally formulated tenofovir 1% topical gel applied rectally will be acceptable to participants, as indicated by a score in the upper one third of the 10-point Likert scale on intentionality to use in the product in the future
- Conditions
- HIV Prevention, HIV Infections
- Being tested
- Tenofovir, HEC Placebo, Open label tenofovir tablet
- Keywords
- Microbicides, Tenofovir, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Topical gel applied rectally
HEC PlaceboDrug
Placebo gel applied rectally
Open label tenofovir tabletDrug
All participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | Experimental | Not described Receives: Drug: Tenofovir |
| HEC Placebo | Placebo comparator | Not described Receives: Drug: HEC Placebo |
| Open label tenofovir tablet | Other | Not described Receives: Drug: Open label tenofovir tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0,Dec 2004 and Addenda 1 and 3 to this table.
Measured: Every study visit
Secondary outcomes (1)
Immunotoxicity, Pharmacokinetics, and Acceptability
Measured: Immunotoxicity and pharmacokinetics: every study visit; acceptability: baseline and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJul 2010
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 HIV PreventionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Microbicide Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984971
- Sponsor's protocol ID
- DAIDS ID 10769
- Other IDs
- RMP02-MTN006
- Acronym
- RMP02-MTN006
- Status last verified
- Aug 2015
- First submitted
- 24 Sep 2009
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richardson-Harman N, Hendrix CW, Bumpus NN, Mauck C, Cranston RD, Yang K, Elliott J, Tanner K, McGowan I, Kashuba A, Anton PA. Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study. PLoS One. 2014 Oct 28;9(10):e111507. doi: 10.1371/journal.pone.0111507. eCollection 2014.
PubMed 25350130Yang KH, Hendrix C, Bumpus N, Elliott J, Tanner K, Mauck C, Cranston R, McGowan I, Richardson-Harman N, Anton PA, Kashuba AD. A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate. PLoS One. 2014 Oct 28;9(10):e106196. doi: 10.1371/journal.pone.0106196. eCollection 2014.
PubMed 25350119Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Dieguez A, Mauck C, McGowan I. RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1412-21. doi: 10.1089/aid.2012.0262. Epub 2012 Oct 9.
PubMed 22943559Richardson-Harman N, Mauck C, McGowan I, Anton P. Dose-response relationship between tissue concentrations of UC781 and explant infectibility with HIV type 1 in the RMP-01 rectal safety study. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1422-33. doi: 10.1089/AID.2012.0073. Epub 2012 Sep 20.
PubMed 22900504
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adults
- ClinicalTrials.gov ID
- NCT00984971
- Acronym / sponsor ID
- RMP02-MTN006 / DAIDS ID 10769
- Conditions
- HIV Prevention, HIV Infections
- Keywords
- Microbicides, Tenofovir, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Microbicide Trials Network
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Sep 2009 (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.
To date, the majority of microbicide research has focused on the assessment of the safety and effectiveness of vaginal microbicides used for the prevention of HIV transmission via the vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with men (MSM), 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. Therefore, the primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally. In addition, this study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK) profiles.
This study was designed to address the following hypotheses:
- Vaginally-formulated tenofovir 1% topical gel when applied rectally will be safe using a combination of clinical and laboratory markers including assays specifically designed to measure mucosal toxicity
- Tenofovir will be detectable at different concentrations in the various anatomic compartments sampled for pharmacokinetics following single and 7-day topical exposures
- Exposure to tenofovir 1% gel will demonstrate prevention of ex vivo HIV-1 challenge using in vivo drug-exposed tissue as compared to baseline tissue samples
- Orally delivered, single dose, 300 mg tenofovir disoproxil fumarate tablets will have similar safety profiles using routine blood safety indices as have been established in other trials and will show no mucosal safety concerns
- The oral dose will have different multi-compartment concentration kinetics than the topical tenofovir and will also demonstrate preliminary (ex vivo) prevention using the explant infectivity assay
- Vaginally formulated tenofovir 1% topical gel applied rectally will be acceptable to participants, as indicated by a score in the upper one third of the 10-point Likert scale on intentionality to use in the product in the future
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | Experimental | Drug: Tenofovir |
| HEC Placebo | Placebo comparator | Drug: HEC Placebo |
| Open label tenofovir tablet | Other | Drug: Open label tenofovir tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥ Age of 18 at screening
- Willing and able to provide written informed consent for screening and enrollment
- HIV-1 uninfected at screening according to the standard DAIDS algorithm in Appendix II
- Willing and able to communicate in English
- Willing and able to provide adequate locator information, as defined in site standard operating procedures (SOP)
Key exclusion criteria (33 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 of the local mucosa, and presence of symptomatic external hemorrhoids)
- At screening, clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines or urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that HSV-2 seropositive with no active lesions is allowed, since treatment is not required.
- Note: Allow one re-screening after documented treatment (30 days) in cases of GC/CT identified at screening
- At screening:
- History of significant gastrointestinal bleeding in the opinion of the investigator
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 |
|---|---|---|
| TenofovirTopical gel applied rectally | Drug | Tenofovir |
| HEC PlaceboPlacebo gel applied rectally | Drug | HEC Placebo |
| Open label tenofovir tabletAll participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®) | Drug | Open label tenofovir tablet |
Primary outcome
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0,Dec 2004 and Addenda 1 and 3 to this table.
Time frame: Every study visit
1 secondary outcome
Immunotoxicity, Pharmacokinetics, and Acceptability
Time frame: Immunotoxicity and pharmacokinetics: every study visit; acceptability: baseline and end 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 Aug 2015.
- Derived from this study: PubMed 25350130Richardson-Harman N, Hendrix CW, Bumpus NN, Mauck C, Cranston RD, Yang K, Elliott J, Tanner K, McGowan I, Kashuba A, Anton PA. Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study. PLoS One. 2014 Oct 28;9(10):e111507. doi: 10.1371/journal.pone.0111507. eCollection 2014.
- Derived from this study: PubMed 25350119Yang KH, Hendrix C, Bumpus N, Elliott J, Tanner K, Mauck C, Cranston R, McGowan I, Richardson-Harman N, Anton PA, Kashuba AD. A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate. PLoS One. 2014 Oct 28;9(10):e106196. doi: 10.1371/journal.pone.0106196. eCollection 2014.
- Derived from this study: PubMed 22943559Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Dieguez A, Mauck C, McGowan I. RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1412-21. doi: 10.1089/aid.2012.0262. Epub 2012 Oct 9.
- Derived from this study: PubMed 22900504Richardson-Harman N, Mauck C, McGowan I, Anton P. Dose-response relationship between tissue concentrations of UC781 and explant infectibility with HIV type 1 in the RMP-01 rectal safety study. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1422-33. doi: 10.1089/AID.2012.0073. Epub 2012 Sep 20.
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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.
2 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 and Open label tenofovir tablet in people with HIV Prevention and HIV Infections, run by CONRAD at 2 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 14 inclusion and 33 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0,Dec 2004 and Addenda 1 and 3 to this table. (time frame: Every study visit). 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 NCT00984971, 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 Aug 2015.