HIV InfectionsNCT00075062
A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- What is being tested?
- Flexible Sigmoidoscopy and Rectal Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV status confirmed by ELISA/Western Blot at screening
- CD4 count greater than 200 cells/mm3 at screening
- Able and willing to communicate in English
- Able and willing to provide adequate information for locator purposes
- Inclusion Criteria for Men Practicing Anal-Receptive Sex (Groups 1, 3 and 4):
- Engaged in anal-receptive sex an average of at least once a week in the 2 months prior to study entry
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- Agree to refrain from anal intercourse for 24 hours prior to and for one week after sigmoidoscopy
- Inclusion Criteria for Men Not Practicing Anal-Receptive Sex (Group 2)
- No history of anal receptive intercourse in the 2 months prior to study entry
- Viral load of either greater than 10,000 copies of RNA/ml plasma or less than 50 copies RNA/ml plasma for at least 2 months prior to study entry
- Have not changed antiretroviral therapy within 6 weeks prior to study entry
Who cannot join
- For HIV infected patients, 3 or more HSV-2 (herpes) outbreaks in the 12 months prior to screening or 1 or more HSV-2 outbreaks in the 6 months prior to screening
- Active, serious infections (other than HIV) requiring parenteral antibiotic therapy within 15 days prior to screening
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease) or rectal cancer
- Rectal surgery, including fistulectomy
- Diagnosed bleeding disorder, including hemophilia, thrombocytopenia, impaired blood clotting, or current use of anticoagulants that, in the opinion of the investigator, would make participation in the study unsafe or complicate interpretation of study outcome data
- Prosthetic heart valve or diagnosis of valve abnormality
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- Hemorrhoid surgery in the 6 months prior to screening
- Bleeding hemorrhoids at screening or in the 6 weeks prior to study entry
- Anal fistulae in the 6 weeks prior to study entry
- Active diarrheal disease (greater than 3 times a day) or bleeding disorder
- Rectal cultures positive for chlamydia or gonorrhea at screening or within 1 month prior to study entry
- Unprotected anal intercourse in the 3 months prior to study entry
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with study requirements
- Enrolled in any other clinical trial for the duration of their participation in HPTN 056
Trial locations and contacts
1 site in 1 country.
United States1 site
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
About this study
Official title: Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides.
Read the detailed description
Rectal microbicides to prevent HIV transmission are currently being developed in the hope that someday they will be widely used to prevent sexually transmitted HIV. This study will examine variables in male rectal tissue; this information may be useful for future rectal microbicide safety and efficacy studies. The study will evaluate the differences in rectal tissue from HIV infected or uninfected males who either engage in anal-receptive sex (men who sleep with men, or MSM) or do not have anal-receptive sex.
The study will last approximately 7 months, with 6 weeks of follow-up. There are four groups in this study. Groups 1 and 2 will enroll HIV uninfected men; Groups 3 and 4 will enroll HIV infected men. Groups 1, 3, and 4 will comprise MSM who engage in anal-receptive sex; Group 2 will comprise men who do not. Patients will provide medical and medication history, undergo a complete physical exam, and receive HIV counseling at screening. An anoscopy (examination of the anus, anal canal, and lower rectum) and blood draw will be conducted at screening, study entry, and Weeks 2 and 4. Rectal secretions will be collected and a sigmoidoscopy (an internal examination of the rectum, distal sigmoid colon, and large bowel using a small camera) will be performed at study entry and Weeks 2 and 4.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- Flexible Sigmoidoscopy, Rectal Biopsy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible SigmoidoscopyProcedure or surgery
Rectal BiopsyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 16 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Investigators
- Ian McGowan, MD, PhD, Study chair, University of California, Los AngelesPeter Anton, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075062
- Sponsor's protocol ID
- HPTN 056
- Status last verified
- May 2006
- First submitted
- 31 Dec 2003
- Last updated
- 21 Aug 2008
- Results posted
- No
Publications
Baron S, Poast J, Nguyen D, Cloyd MW. Practical prevention of vaginal and rectal transmission of HIV by adapting the oral defense: use of commercial lubricants. AIDS Res Hum Retroviruses. 2001 Jul 20;17(11):997-1002. doi: 10.1089/088922201300343672.
PubMed 11485616Garg S, Tambwekar KR, Vermani K, Kandarapu R, Garg A, Waller DP, Zaneveld LJ. Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges. AIDS Patient Care STDS. 2003 Aug;17(8):377-99. doi: 10.1089/108729103322277402.
PubMed 13678540Gross M, Buchbinder SP, Celum C, Heagerty P, Seage GR 3rd. Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team. Sex Transm Dis. 1998 Jul;25(6):296-302. doi: 10.1097/00007435-199807000-00005.
PubMed 9662763
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
- ClinicalTrials.gov ID
- NCT00075062
- Acronym / sponsor ID
- HPTN 056
- Conditions
- HIV Infections, HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- First posted
- 1 Jan 2004 (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.
Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides.
Detailed description
Rectal microbicides to prevent HIV transmission are currently being developed in the hope that someday they will be widely used to prevent sexually transmitted HIV. This study will examine variables in male rectal tissue; this information may be useful for future rectal microbicide safety and efficacy studies. The study will evaluate the differences in rectal tissue from HIV infected or uninfected males who either engage in anal-receptive sex (men who sleep with men, or MSM) or do not have anal-receptive sex.
The study will last approximately 7 months, with 6 weeks of follow-up. There are four groups in this study. Groups 1 and 2 will enroll HIV uninfected men; Groups 3 and 4 will enroll HIV infected men. Groups 1, 3, and 4 will comprise MSM who engage in anal-receptive sex; Group 2 will comprise men who do not. Patients will provide medical and medication history, undergo a complete physical exam, and receive HIV counseling at screening. An anoscopy (examination of the anus, anal canal, and lower rectum) and blood draw will be conducted at screening, study entry, and Weeks 2 and 4. Rectal secretions will be collected and a sigmoidoscopy (an internal examination of the rectum, distal sigmoid colon, and large bowel using a small camera) will be performed at study entry and Weeks 2 and 4.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV status confirmed by ELISA/Western Blot at screening
- CD4 count greater than 200 cells/mm3 at screening
- Able and willing to communicate in English
- Able and willing to provide adequate information for locator purposes
- Engaged in anal-receptive sex an average of at least once a week in the 2 months prior to study entry
Key exclusion criteria (14 listed)
- For HIV infected patients, 3 or more HSV-2 (herpes) outbreaks in the 12 months prior to screening or 1 or more HSV-2 outbreaks in the 6 months prior to screening
- Active, serious infections (other than HIV) requiring parenteral antibiotic therapy within 15 days prior to screening
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease) or rectal cancer
- Rectal surgery, including fistulectomy
- Diagnosed bleeding disorder, including hemophilia, thrombocytopenia, impaired blood clotting, or current use of anticoagulants that, in the opinion of the investigator, would make participation in the study unsafe or complicate interpretation of study outcome data
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 |
|---|---|---|
| Flexible Sigmoidoscopy | Procedure or surgery | – |
| Rectal Biopsy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Aug 2008.
- Background: PubMed 11485616Baron S, Poast J, Nguyen D, Cloyd MW. Practical prevention of vaginal and rectal transmission of HIV by adapting the oral defense: use of commercial lubricants. AIDS Res Hum Retroviruses. 2001 Jul 20;17(11):997-1002. doi: 10.1089/088922201300343672.
- Background: PubMed 13678540Garg S, Tambwekar KR, Vermani K, Kandarapu R, Garg A, Waller DP, Zaneveld LJ. Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges. AIDS Patient Care STDS. 2003 Aug;17(8):377-99. doi: 10.1089/108729103322277402.
- Background: PubMed 9662763Gross M, Buchbinder SP, Celum C, Heagerty P, Seage GR 3rd. Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team. Sex Transm Dis. 1998 Jul;25(6):296-302. doi: 10.1097/00007435-199807000-00005.
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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 study chair
University of California, Los Angeles
Peter Anton, MD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 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 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075062, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.