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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:September 2007
End Date:September 2009

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

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.

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.

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 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:

- 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 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:

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.
We found this trial at
8
sites
Los Angeles, California 90034
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Anaheim, California 92807
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Anaheim, CA
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Hayward, California 95454
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Hayward, CA
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Los Angeles, California 95864
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Los Angeles, CA
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Panorama City, California 91402
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Panorama City, CA
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San Francisco, California 94118
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San Francisco, CA
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Santa Clara, California 95051
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Santa Clara, CA
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Santa Clarita, California 91355
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Santa Clarita, CA
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