HIV InfectionsPhase 1NCT00069498
Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
A Phase 1 study testing 5-aminosalicylic acid in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- 5-aminosalicylic acid
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to not given
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry
- Stable antiretroviral therapy for at least 3 months prior to study entry
- CD4 cell count greater than or equal to 200 cells/mm3
- Mucosal viral RNA greater than or equal to 100 copies/microg total RNA within 2 weeks of study entry
Who cannot join
- Allergy or intolerance to salicylates
- Gastrointestinal tract infection causing diarrhea or colonic inflammation
- Renal or hepatic disease
- Current opportunistic infection
- History of extensive small bowel resection (greater than 1/2 the length of the small intestine)
- History of intestinal mucosal disease (except HIV)
Show all 10Show fewer
- Chronic, regular use of aspirin and/or anti-inflammatory agents within 7 weeks prior to study entry
- Oral, topical, or rectal steroids or 5-ASA within 3 months prior to study entry
- Certain laboratory abnormalities
- Significant neuropsychiatric symptoms that in the opinion of the study official could impact the conduct or outcome of the study
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: Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa
The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV.
Read the detailed description
The gastrointestinal tract is the body's largest lymphoid organ. Because it contains significant numbers of activated memory T lymphocytes, it is a prime site for HIV infection and amplification. Mucosal T cells are extremely vulnerable to HIV infection due, in part, to a marked increase in CCR5 co-receptors. Understanding the impact of HIV on the gastrointestinal-associated lymphoid tissue (GALT) is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral replication in the setting of undetectable plasma viral activity, and compartmentalization of HIV.
Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood. Once infected, the mucosal response to HIV is inflammation. This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa.
Participants in this study will be randomly assigned to receive either 5-ASA or placebo. Participants will be enrolled in the study for 8 weeks; participants may then elect to continue on 5-ASA for an additional 16 weeks. Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study. Assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal biopsy, and blood tests.
- Conditions
- HIV Infections
- Being tested
- 5-aminosalicylic acid
- Keywords
- Mucosa, Inflammation, Tissue Viral Load, Anti-inflammatory, HIV-related diarrhea, Mucosal Inflammation, Treatment Experienced
- Medical subject headings
- HIV Infections, Inflammation, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-aminosalicylic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load
Secondary outcomes (5)
Time/trend decrease in mucosal viral RNA load and plasma viral RNA load, compared to placebo
reduction in cellular infiltration in treated patients versus those taking placebo
change in inflammation, as measured by tissue destruction
reduction in soluble inflammation (RANTES), CCR5 expression, and cellular infiltration of CD8
changes in certain activation markers in gut
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2003 (estimated)
- Study startOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 14 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter A. Anton, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069498
- Sponsor's protocol ID
- K24AI001610-03
- Other IDs
- K24AI001610-03
- Status last verified
- Jul 2006
- First submitted
- 26 Sep 2003
- Last updated
- 25 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa
- ClinicalTrials.gov ID
- NCT00069498
- Acronym / sponsor ID
- K24AI001610-03
- Conditions
- HIV Infections
- Keywords
- Mucosa, Inflammation, Tissue Viral Load, Anti-inflammatory, HIV-related diarrhea, Mucosal Inflammation, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 1999
- First posted
- 30 Sep 2003 (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.
The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV.
Detailed description
The gastrointestinal tract is the body's largest lymphoid organ. Because it contains significant numbers of activated memory T lymphocytes, it is a prime site for HIV infection and amplification. Mucosal T cells are extremely vulnerable to HIV infection due, in part, to a marked increase in CCR5 co-receptors. Understanding the impact of HIV on the gastrointestinal-associated lymphoid tissue (GALT) is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral replication in the setting of undetectable plasma viral activity, and compartmentalization of HIV.
Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood. Once infected, the mucosal response to HIV is inflammation. This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa.
Participants in this study will be randomly assigned to receive either 5-ASA or placebo. Participants will be enrolled in the study for 8 weeks; participants may then elect to continue on 5-ASA for an additional 16 weeks. Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study. Assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal biopsy, and blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infected
- Stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry
- Stable antiretroviral therapy for at least 3 months prior to study entry
- CD4 cell count greater than or equal to 200 cells/mm3
- Mucosal viral RNA greater than or equal to 100 copies/microg total RNA within 2 weeks of study entry
Key exclusion criteria (10 listed)
- Allergy or intolerance to salicylates
- Gastrointestinal tract infection causing diarrhea or colonic inflammation
- Renal or hepatic disease
- Current opportunistic infection
- History of extensive small bowel resection (greater than 1/2 the length of the small intestine)
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 |
|---|---|---|
| 5-aminosalicylic acid | Drug | – |
Primary outcome
Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load
5 secondary outcomes
Time/trend decrease in mucosal viral RNA load and plasma viral RNA load, compared to placebo
reduction in cellular infiltration in treated patients versus those taking placebo
change in inflammation, as measured by tissue destruction
reduction in soluble inflammation (RANTES), CCR5 expression, and cellular infiltration of CD8
changes in certain activation markers in gut
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 25 May 2007.
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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.
Peter A. Anton, MD principal investigator
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?
A Phase 1 study testing 5-aminosalicylic acid in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 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 25 May 2007. 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.
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?
Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2007.