HIV-1-infectionPhase 1/2NCT03399903
Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
A Phase 1/2 study testing Pentasa vs Align in people with HIV-1-infection and Gut Inflammation, run by AIDS Healthcare Foundation at 1 site in United States.
Trial summary
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Gut Inflammation
- What is being tested?
- Pentasa vs Align
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 22 Mar 2019
- Phase
- Phase 1/2
- 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 at least 18
- On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time
- CD4 T cell nadir >350
- Last CD4 and T cell test in past 6 months
Who cannot join
- Plans to modify antiretroviral therapy in the next 12 weeks for any reason
- History of inflammatory bowel disease or irritable bowel disease
- Chronic active hepatitis B or C
- History of autoimmune disease
- Hypersensitivity to any component of Pentasa
- Clostridium difficile infection
Show all 19Show fewer
- Receiving rectally delivered medications
- Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
- Receiving immunosuppressive steroids
- Receiving any medications associated with bleeding risk
- 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
- Symptoms of sexually transmitted infection
- Antibiotics used in the last 90 days
- Renal insufficiency with creatinine clearance less than 50 ml/min
- Elevated transaminases greater than 2.5 times the upper limit of normal
- Evidence of decompensated cirrhosis, heart failure
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Healthcare Foundation - Public Health Division
Los Angeles, California, 90027
About this study
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Read the detailed description
The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
- Conditions
- HIV-1-infection, Gut Inflammation
- Being tested
- Pentasa vs Align
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentasa vs AlignDrug
We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
| Study group | Role | What they receive |
|---|---|---|
| Pentasa | Experimental | 40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks Receives: Drug: Pentasa vs Align |
| Align | Active comparator | 40 participants will be randomized to take Align tablets, once daily for 8 weeks Receives: Drug: Pentasa vs Align |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation markers
C-reactive protein
Measured: 14 weeks
Secondary outcomes (2)
Flow cytometry for cellular immune activation
Immune activation
Measured: 14 weeks
Plasma markers of microbial translocation
Microbial translocation
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 May 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Healthcare Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- HIV Immunotherapeutics Institute
- Responsible party
- Sponsor
- Investigators
- Otto O Yang, MD, Study director, AIDS Healthcare Foundation - HIV Immunotherapeutics InstitutePeter Anton, MD, Principal investigator, AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399903
- Sponsor's protocol ID
- HII-03
- Status last verified
- Mar 2020
- First submitted
- 9 Jan 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
- ClinicalTrials.gov ID
- NCT03399903
- Acronym / sponsor ID
- HII-03
- Conditions
- HIV-1-infection, Gut Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AIDS Healthcare FoundationUniversity, hospital or other
- Collaborators
- HIV Immunotherapeutics Institute
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Detailed description
The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentasa | Experimental | Drug: Pentasa vs Align40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks |
| Align | Active comparator | Drug: Pentasa vs Align40 participants will be randomized to take Align tablets, once daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age at least 18
- On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time
- CD4 T cell nadir >350
- Last CD4 and T cell test in past 6 months
Key exclusion criteria (19 listed)
- Plans to modify antiretroviral therapy in the next 12 weeks for any reason
- History of inflammatory bowel disease or irritable bowel disease
- Chronic active hepatitis B or C
- History of autoimmune disease
- Hypersensitivity to any component of Pentasa
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 |
|---|---|---|
| Pentasa vs AlignWe will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection. | Drug | Align, Pentasa |
Primary outcome
Inflammation markers
Time frame: 14 weeks
C-reactive protein
2 secondary outcomes
Flow cytometry for cellular immune activation
Time frame: 14 weeks
Plasma markers of microbial translocation
Time frame: 14 weeks
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 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Otto O Yang, MD study director
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
Peter Anton, MD principal investigator
AIDS Healthcare Foundation - HIV Immunotherapeutics Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pentasa vs Align in people with HIV-1-infection and Gut Inflammation, run by AIDS Healthcare Foundation 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 4 inclusion and 19 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 4 Mar 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Inflammation markers (time frame: 14 weeks). 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 4 Mar 2020.