Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661960
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : January 16, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.

Condition or disease Intervention/treatment Phase
HIV Infections AIDS Drug: raltegravir Drug: efavirenz Not Applicable

Detailed Description:
While the world-wide AIDS epidemic continues to impact millions of individuals, effective anti-HIV medications have substantially reduced morbidity and mortality for those patients able to adhere to combination regimens. Despite improved survival, durable virologic suppression, and increases in peripheral CD4+T-cell counts in patients receiving potent antiretroviral therapy (ART), immune reconstitution remains incomplete as measured by a number of additional surrogate markers. Perhaps critically important among areas of apparent incomplete immune recovery is the gastrointestinal-associated lymphoid tissue (GALT), where CD4+T-cells repopulate very slowly, if at all. Raltegravir is a new ART agent from a novel class of HIV inhibitors, integrase inhibitors, that results in rapid suppression of HIV and recovery of peripheral CD4+T-cells. This project proposes to examine whether volunteers receiving raltegravir recover GALT immune cells more completely than those taking comparator ART.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Raltegravir Therapy
Study Start Date : March 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: 1
HIV Negative volunteers
Active Comparator: 2
HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
Drug: raltegravir
400mg tablet twice daily by mouth for nine months
Other Name: Isentress

Active Comparator: 3
HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
Drug: efavirenz
600mg capsule once daily by mouth without regard to food
Other Name: Sustiva

Primary Outcome Measures :
  1. the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time. [ Time Frame: nine months ]
    Duodenal tissue immune cell subsets were measured by flow cytometry.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • willing to sign consent form
  • no known GI pathology
  • no anticipated antiretroviral therapy adjustments or changes
  • males & females between the ages of 18 & 50 years
  • no active opportunistic infections (OI) or therapy for OI within 30 days of entry
  • can be on secondary prophylaxis with a history of AIDS defining illness
  • per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study

Exclusion Criteria:

  • abnormal coagulation parameters (PT > or equal to 1.2 ULN)
  • thrombocytopenia (platelet count < 50,000 within 6 weeks)
  • contra-indications to upper endoscopy or conscious sedation
  • anemia (> or equal to grade 1)
  • aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661960

United States, California
CARES Clinic
Sacramento, California, United States, 95814
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: David M. Asmuth, M.D. University of California, Davis

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, Davis Identifier: NCT00661960     History of Changes
Other Study ID Numbers: 200715792
First Posted: April 21, 2008    Key Record Dates
Results First Posted: January 16, 2017
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
HIV Positive
Antiretroviral Therapy
Gastrointestinal-Associated Lymphoid Tissue
Immune Reconstitution
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers