Clinical trial NCT00529243: Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
Official title: Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Treatment Experience
On enfuvirtide
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-09-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
timeFrame: 24 Weeks
Secondary outcomes:
measure: Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Kaiser Anaheim
state: California
city: Hayward
country: United States
facility: Kaiser Hayward
state: California
city: Los Angeles
country: United States
facility: Kaiser Los Angeles
state: California
city: Los Angeles
country: United States
facility: Kaiser West Los Angeles
state: California
city: Panorama City
country: United States
facility: Kaiser Panorama City
state: California
city: San Francisco
country: United States
facility: Kaiser San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Santa Clara
state: California
city: Santa Clarita
country: United States
facility: Kaiser Santa Clarita
state: California
Study officials:
affiliation: Kaiser Permanente
name: William J Towner, MD
role: PRINCIPAL_INVESTIGATOR
References: