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

NCT00661960 | Completed Results

• 1 other identifier: 200715792
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections; AIDS

Keywords

HIV Positive; AIDS; Antiretroviral Therapy; Gastrointestinal-Associated Lymphoid Tissue; Immune Reconstitution; treatment experienced

Outcome Measures

Primary Outcomes (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.

  Duodenal tissue immune cell subsets were measured by flow cytometry.

  nine months

Study Arms (3)

1

NO INTERVENTION

HIV Negative volunteers

2

ACTIVE COMPARATOR

HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications

Drug: raltegravir

3

ACTIVE COMPARATOR

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

Interventions

raltegravir DRUG

400mg tablet twice daily by mouth for nine months

Also known as: Isentress

2

efavirenz DRUG

600mg capsule once daily by mouth without regard to food

Also known as: Sustiva

3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

CARES Clinic

Sacramento, California, 95814, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (2)

• 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 reverse transcriptase inhibitor-based regimens. AIDS. 2012 Aug 24;26(13):1625-34. doi: 10.1097/QAD.0b013e3283546595.

  PMID: 22820612 RESULT

• Ellis CL, Ma ZM, Mann SK, Li CS, Wu J, Knight TH, Yotter T, Hayes TL, Maniar AH, Troia-Cancio PV, Overman HA, Torok NJ, Albanese A, Rutledge JC, Miller CJ, Pollard RB, Asmuth DM. Molecular characterization of stool microbiota in HIV-infected subjects by panbacterial and order-level 16S ribosomal DNA (rDNA) quantification and correlations with immune activation. J Acquir Immune Defic Syndr. 2011 Aug 15;57(5):363-70. doi: 10.1097/QAI.0b013e31821a603c.

  PMID: 21436711 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; HIV Seropositivity

Interventions

Raltegravir Potassium; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations of the study include small numbers of subjects over all - Several subjects dropped out due to moving out of the region and lost to follow up.

Results Point of Contact

• Title: David Asmuth/Principal Investigator
• Organization: UCaliforniaDavis

david.asmuth@ucdmc.ucdavis.edu

9167348695

Study Officials

• David M. Asmuth, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2011
• Last Updated: May 30, 2017
• Results First Posted: January 16, 2017

Record last verified: 2017-05

Locations

US (2)