Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: raltegravir
Intervention description: This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (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 ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experience; On enfuvirtide

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.
    

Eligibility 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 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.