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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HIV Negative volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type ACTIVE_COMPARATOR

raltegravir

Intervention Type DRUG

400mg tablet twice daily by mouth for nine months

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

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

600mg capsule once daily by mouth without regard to food

Interventions

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raltegravir

400mg tablet twice daily by mouth for nine months

Intervention Type DRUG

efavirenz

600mg capsule once daily by mouth without regard to food

Intervention Type DRUG

Other Intervention Names

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Isentress Sustiva

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes