Mesalamine to Reduce T Cell Activation in HIV Infection

NCT01090102 | Completed Phase 4 Results

• 1 other identifier: 164320
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected patients, possibly resulting in better recovery of the immune system. The study hypothesis is that decreasing inflammation directly in the gut may decrease both of these potential causes of chronic inflammation, potentially resulting in an immunologic benefit.

Conditions

HIV Infections; Sexually Transmitted Diseases; Immune System Diseases; Lentivirus Infections; Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (1)

• Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study

  Week 0, Week 12

Secondary Outcomes (1)

• Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover

  Week 12, Week 24

Study Arms (2)

Mesalamine

EXPERIMENTAL

Drug: Mesalamine (5-aminosalicylic acid, Apriso)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mesalamine (5-aminosalicylic acid, Apriso) DRUG

Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth). Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).

Mesalamine

Placebo DRUG

Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth). Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
• Stable antiretroviral therapy for at least 6 months.
• Screening CD4+ T cell count below 350 cells/mm3
• All available CD4+ T cell counts in the last year and at screening \<350 cells/mm3
• Screening plasma HIV RNA levels below level of detection (\< 40 copies RNA/mL).
• All available plasma HIV RNA levels within past year below the level of detection. Isolated detectable values \< 500 c/ml are allowed if HIV RNA levels before and after this time point are undetectable.
• \>90% adherence to therapy within the preceding 30 days, as determined by self-report.
• Both male and female subjects are eligible. Females of childbearing potential must have negative pregnancy test at screening and agree to use a double-barrier method of contraception during the study.

You may not qualify if:

• Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
• Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
• Exposure to any immunomodulatory drug in the past 16 weeks.
• Active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
• Screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<50,000 cells/mm3, Hgb \< 8mg/dL
• Pancreatitis or lipase greater than 2 times the upper limit of normal.
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California HIV/AIDS Research Program: collaborator
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University of California, San Francisco-San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Somsouk M, Dunham RM, Cohen M, Albright R, Abdel-Mohsen M, Liegler T, Lifson J, Piatak M, Gorelick R, Huang Y, Wu Y, Hsue PY, Martin JN, Deeks SG, McCune JM, Hunt PW. The immunologic effects of mesalamine in treated HIV-infected individuals with incomplete CD4+ T cell recovery: a randomized crossover trial. PLoS One. 2014 Dec 29;9(12):e116306. doi: 10.1371/journal.pone.0116306. eCollection 2014.

  PMID: 25545673 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Immune System Diseases; Lentivirus Infections; Acquired Immunodeficiency Syndrome

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Dr. Ma Somsouk
• Organization: University of California, San Francisco

somsoukma@medsfgh.ucsf.edu

415-206-6480

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 13, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-08

Locations

US (1)