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Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects | Clinical Trials | Clareo Health

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Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen

NCT00529243•Kaiser Permanente

View on ClinicalTrials.gov

Summary

The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen. Hypothesis: HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.

Detailed Description

Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study.
•2. Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24 assay, HIV-1 RNA, or culture).
•3. Have documented plasma HIV-1 RNA level(s) of \< 75 copies/ml by branched deoxyribonucleic acid(bDNA) assay, or \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) for at least 6 months prior to screening visit.
•4. Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months.
•5. Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.

Exclusion Criteria

•1. Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.
•2. Any HIV-1 viral load \> 75 copies/ml by bDNA assay, or \> 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single "blip" of HIV-1 viral load \>75 copies but \<400 copies by bDNA assay, or \>50 copies but \<400 copies by Ultrasensitive PCR assay in the six months prior to screening visit with at least one subsequent HIV-1 viral load below the limit of detection will be accepted.)
•3. Any previous known hypersensitivity to components of the study drug formulation.
•4. Weight \< 40 kilograms.
•5. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
•6. Acute therapy for serious illness (in the opinion of the investigator) within 14 days prior to study entry unless the subject has completed ≥ 7 days of therapy and is considered clinically stable by the investigator.
•7. Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
•8. Any active opportunistic infections or Centers for Disease Control and Prevention (CDC) Category C conditions (with the exception of stable cutaneous Kaposi's Sarcoma and wasting syndrome due to HIV infection).
•9. Any malignancy requiring chemotherapy.
•10. Subject has any of the following laboratory results at screening:
+2 more criteria

Locations (8)

Kaiser Anaheim

Anaheim, California, United States

Kaiser Hayward

Hayward, California, United States

Kaiser Los Angeles

Los Angeles, California, United States

Kaiser West Los Angeles

Los Angeles, California, United States

Kaiser Panorama City

Panorama City, California, United States

Kaiser San Francisco

San Francisco, California, United States

Kaiser Santa Clara

Santa Clara, California, United States

Kaiser Santa Clarita

Santa Clarita, California, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

July 1, 2008

Completion Date

September 1, 2009

Last Updated

August 7, 2018

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

raltegravir

DRUG

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HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

Inclusion Criteria

Exclusion Criteria

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