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

HIV Infections Clinical Trial

Official title:

A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Raltegravir Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661960
• Other study ID #: 200715792
• Status: Completed
• Phase: N/A
• First received: April 16, 2008
• Last updated: May 24, 2017
• Start date: March 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• raltegravir
400mg tablet twice daily by mouth for nine months
• efavirenz
600mg capsule once daily by mouth without regard to food

Locations

Country	Name	City	State
United States	CARES Clinic	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Asmuth DM, Ma ZM, Mann S, Knight TH, Yotter T, Albanese A, Melcher GP, Troia-Cancio P, Hayes T, Miller CJ, Pollard RB. Gastrointestinal-associated lymphoid tissue immune reconstitution in a randomized clinical trial of raltegravir versus non-nucleoside re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duodenal tissue immune cell subsets were measured by flow cytometry.	nine months