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

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ClinicalTrials.gov 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

April 16, 2008
April 21, 2008
January 18, 2013
January 16, 2017
May 30, 2017
March 2008
September 2010   (Final data collection date for primary outcome measure)
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.
To correlate the increase in frequency 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 ]
Complete list of historical versions of study NCT00661960 on ClinicalTrials.gov Archive Site
Not Provided
  • To measure the trough plasma and tissue drug levels in volunteers at the time of the upper endoscopy [ Time Frame: nine months ]
  • To correlate the level of HIV RNA per gram of duodenal tissue versus plasma HIV load and drug regimen received [ Time Frame: nine months ]
  • To measure the change in GALT CD4+ and CD8+T-cell subpopulations (naive versus memory) in volunteers receiving raltegravir versus NNRTI [ Time Frame: nine months ]
  • To assess GALT immune function and activation in volunteers receiving raltegravir versus NNRTI [ Time Frame: nine months ]
  • To explore whether the treatment regimen correlates with the changes in CD3+/CD4+ T-cell numbers [ Time Frame: nine months ]
  • To compare the level of immune reconstitution with respect to absolute numbers of CD4+ T-cells, the relative proportion of T-cell subpopulations in the tissue, and immune activation to a cohort of normal controls [ Time Frame: nine months ]
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Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Raltegravir Therapy
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
  • Drug: raltegravir
    400mg tablet twice daily by mouth for nine months
    Other Name: Isentress
  • Drug: efavirenz
    600mg capsule once daily by mouth without regard to food
    Other Name: Sustiva
  • 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
    Intervention: Drug: raltegravir
  • 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
    Intervention: Drug: efavirenz

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2011
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: David M. Asmuth, M.D. University of California, Davis
University of California, Davis
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP