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

NCT00529243 | Completed Phase 3 Results

• 1 other identifier: 4908
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV Infections

Keywords

Treatment Experience; On enfuvirtide

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.

  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 HIV (undetectable level of serum HIV defined as \< 75 copies/ml by bDNA assay or \< 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.

  24 Weeks

Secondary Outcomes (1)

• Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24

  24 Weeks

Study Arms (1)

MK-0518 (raltegravir)

EXPERIMENTAL

Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Drug: raltegravir

Interventions

raltegravir DRUG

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.

Also known as: MK-0518, Isentress

MK-0518 (raltegravir)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (8)

Kaiser Anaheim

Anaheim, California, 92807, United States

Location

Kaiser Hayward

Hayward, California, 95454, United States

Location

Kaiser Los Angeles

Los Angeles, California, 90027, United States

Location

Kaiser West Los Angeles

Los Angeles, California, 90034, United States

Location

Kaiser Panorama City

Panorama City, California, 91402, United States

Location

Kaiser San Francisco

San Francisco, California, 94118, United States

Location

Kaiser Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Santa Clarita

Santa Clarita, California, 91355, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

A limitation of our study was the lack of a separate control arm. However, patients did serve as their own control by virtue of at least 6 months of HIV-1 ribonucleic acid(RNA)levels below the level of quantification before enrollment in the study.

Results Point of Contact

• Title: William Towner, MD
• Organization: Kaiser Permanente

William.J.Towner@KP.org

323-783-7855

Study Officials

• William J Towner, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2009
• Last Updated: August 7, 2018
• Results First Posted: June 8, 2011

Record last verified: 2018-07

Locations

US (8)