Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00529243
- Run by
- Kaiser Permanente
- People needed
- 52
- Starts
- 2007-09-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2018-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
- 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.
- 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).
- 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.
- Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months.
- 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.
You may not qualify if…
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.
- 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.)
- Any previous known hypersensitivity to components of the study drug formulation.
- Weight < 40 kilograms.
- Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
- 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.
- Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
- 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).
- Any malignancy requiring chemotherapy.
- 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
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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