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Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects (CHEER)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Kaiser Permanente
Merck
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00529243
  Purpose

The primary objective of this study is:

• To assess the virologic effect of changing enfuvirtide to MK-0518 in HIV-1 infected patients who have an undetectable level of serum HIV (< 75 copies/ml by bDNA assay, < 50 copies/ml by Ultrasensitive 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.


Condition Intervention Phase
HIV Infections
Drug: Raltegravir
Phase III

MedlinePlus related topics: AIDS
Drug Information available for: Raltegravir Enfuvirtide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • • To assess the virologic effect of changing enfuvirtide to MK-0518 in HIV-1 infected patients who have an undetectable level of serum HIV (< 75 copies/ml by bDNA assay, < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen [ Time Frame: July 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To study the immunologic effect of changing enfuvirtide to MK-0518 in HIV-1 infected patients who have an undetectable level of serum HIV (< 75 copies/ml by bDNA assay, < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regime [ Time Frame: July 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2007
Estimated Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Open label, single arm. All patients to receive MK-0518 400mg PO BID for 24 weeks, as substitution for enfuvirtide.
Drug: Raltegravir
This is a single-arm, open-label, non-randomized pilot study in HIV-1 positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV RNA below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.

Detailed Description:

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 400mg PO BID as substitution for enfuvirtide for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria to be eligible for participation in this study.

    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 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 bDNA assay, or < 50 copies/ml by Ultrasensitive 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:

  • Patients who meet any of the following exclusion criteria are not to be enrolled in this study.

    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 in the six months prior to screening visit with at least one subsequent HIV-1 viral loads <75 copies will be accepted.)
    3. Any previous known hypersensitivity to components of the study drug formulation.
    4. Weight < 40 kg.
    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 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:

      Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min

    11. Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529243

Locations
United States, California
Kaiser Los Angeles
Los Angeles, California, United States, 90027
Kaiser Hayward
Hayward, California, United States, 95454
Kaiser San Francisco
San Francisco, California, United States, 94118
Kaiser Santa Clara
Santa Clara, California, United States, 95051
Kaiser West Los Angeles
Los Angeles, California, United States, 90034
Kaiser Anaheim
Anaheim, California, United States, 92807
Kaiser Panorama City
Panorama City, California, United States, 91402
Kaiser Santa Clarita
Santa Clarita, California, United States, 91355
Sponsors and Collaborators
Kaiser Permanente
Merck
Investigators
Principal Investigator: William J Towner, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente ( William Towner, MD )
Study ID Numbers: 4908
Study First Received: September 12, 2007
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00529243  
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaiser Permanente:
Treatment Naive

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009