Efficacy and Safety of MK-0518 in Treatment-Experienced HIV-1 Infected Adult Patients With Hemophilia

November 24, 2008 updated by: Shanghai Public Health Clinical Center

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety, Tolerability of MK-0518 in Treatment-Experienced HIV-1 Infected Adult Patients With Hemophilia

This is an randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of MK-0518 compared to placebo when combined with other antiretroviral drugs, in treatment-experienced HIV-infected patients with hemophilia.

Subjects enrolled in the study sign the consent form, then are randomly assigned to MK-0518 400 mg twice daily plus optimized background therapy (OBT) group or placebo plus OBT group.Each group concludes at least 50 subjects. For each patient, detection of HIV viral load and CD4+ T lymphocyte count is done at screening, and at weeks 4, 8, 12 and 24. The safety profile of MK-0518 is monitored according to patients' complaints and the results of physical and laboratory examinations.

The safety and efficacy of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, will be assessed by review of the accumulated study data in HIV-infected patients with hemophilia.

Study Overview

Status

Unknown

Conditions

Detailed Description

  1. Objective

    To assess the safety, tolerability and efficacy of MK-0518 compared to placebo when combined with other antiretroviral drugs, in treatment-experienced HIV-infected patients with hemophilia.

  2. Background and Significance

Current anti-HIV drugs are mainly reverse transcriptase inhibitors, which include nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs), and protease inhibitors(PIs). However, HIV can become rapidly resistant to them due to its high rate of mutation while replicating, which forces people to seek new targets for anti-HIV therapy continually. Integrase is an another enzyme essential for HIV reproduction. To inhibit integrase activity is an effective measure to suppress HIV replication. MK-0518(Raltegravir）was approved by the United States Food and Drug Administration(FDA) on October 12th 2007 due to its potent antiviral activity and became the first-to-market integrase inhibitor.Compared with other antiviral drugs, it has new action mechanism and target site, so there is no cross resistance between it and them, which makes it a good option for patients with multi-drug resistant HIV strains. HIV infection is very common in hemophiliac patients who need continuous infusion of clotting products,and the chance of getting HIV infection for hemophilia patients is very high, especially before 1985 when non-virus-inactivated factor concentrates were widely used. Many hemophilia patients were infected with HIV, and AIDS became their main cause of death.The recommended first-line antiretroviral regimen for HIV/AIDS patients with hemophilia concludes two NRTIs and one NNRTIs, while protease inhibitors are not recommended to use in these patients, because they are likely to worsen bleeding tendency. So, if HIV/AIDS patients with hemophilia are resistant to NRTIs and NNRTIs, there are few remaining options for them to choose as part of second-line drugs. However, MK-0518，a drug with novel anti-HIV mechanism different with NRTIs and NNRTIs, may be used in HIV/AIDS patients with hemophilia as the second-line drug.

3． Study design

  1. Patients Enrollment
  2. Patients enrolled in the study sign consent form
  3. Select an optimized background therapy(OBT) for each subject
  4. Randomization: patients are randomly assigned to MK-0518 400 mg twice daily plus OBT group or placebo plus OBT group, each group concludes at least 50 subjects.
  5. Data collection: for each patient, detection of HIV viral load and CD4+ T lymphocyte count is done at screening, and at weeks4, 8, 12, 16, and 24. The safety profile of MK-0518 is monitored according to patients' complaints and the results of physical and laboratory examinations.
  6. Endpoints of study: The primary endpoint is the the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT.The secondary endpoint is antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jinshan
      • Shanghai, Jinshan, China, 201508
        • Shanghai Public Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

treatment-experienced HIV-1 infected adult patients with hemophilia

Description

Inclusion Criteria:

  • HIV-infected patients with hemophilia aged over 18 who have failed previous antiretroviral treatment are eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data in HIV-infected patients with hemophilia.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Hongzhou Lu, PhD, Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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