Efficacy and Safety of MK-0518 in Treatment-Experienced HIV-1 Infected Adult Patients With Hemophilia
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| ClinicalTrials.gov Identifier: NCT00797381 |
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Recruitment Status : Unknown
Verified November 2008 by Shanghai Public Health Clinical Center.
Recruitment status was: Not yet recruiting
First Posted : November 25, 2008
Last Update Posted : November 25, 2008
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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.
| Condition or disease |
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| HIV Infection Hemophilia A |
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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.
- 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
- Patients Enrollment
- Patients enrolled in the study sign consent form
- Select an optimized background therapy(OBT) for each subject
- 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.
- 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.
- 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 |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case Control |
| Time Perspective: | Prospective |
| Official Title: | 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 |
| Study Start Date : | May 2009 |
| Estimated Primary Completion Date : | October 2010 |
| Estimated Study Completion Date : | May 2011 |
| Group/Cohort |
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| 1 |
| 2 |
- 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 ]
- Antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT. [ Time Frame: 24 weeks ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected patients with hemophilia aged over 18 who have failed previous antiretroviral treatment are eligible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797381
| Contact: Hongzhou Lu, PhD | 0086-2157248758 | luhongzhou@fudan.edu.cn |
| China, Jinshan | |
| Shanghai Public Health Clinical Center | Not yet recruiting |
| Shanghai, Jinshan, China, 201508 | |
| Contact: Hongzhou Lu, PhD 0086-2157248758 luhongzhou@fudan.edu.cn | |
| Principal Investigator: Hongzhou Lu, PhD | |
| Principal Investigator: | Hongzhou Lu, PhD | Shanghai Public Health Clinical Center |
| Responsible Party: | Shanghai Public Health Clinical Center |
| ClinicalTrials.gov Identifier: | NCT00797381 History of Changes |
| Other Study ID Numbers: |
CN2009 |
| First Posted: | November 25, 2008 Key Record Dates |
| Last Update Posted: | November 25, 2008 |
| Last Verified: | November 2008 |
Keywords provided by Shanghai Public Health Clinical Center:
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MK-0518 HIV AIDS hemophilia treatment experienced |
Additional relevant MeSH terms:
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HIV Infections Hemophilia A Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |