HIV Infections Clinical Trial
Official title:
Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
Verified date | December 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
Status | Completed |
Enrollment | 179 |
Est. completion date | July 2009 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study - Patient must be currently on antiretroviral therapy (ART) Exclusion Criteria: - Patient less than 18 years of age - Additional exclusion criteria will be discussed and identified by the study doctor |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases. | Baseline and Week 168 | No |
Other | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases. | Baseline and Week 168 | No |
Primary | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients | Baseline and Week 24 | No |
Secondary | Number of Patients With Virologic Responses at Week 24 | Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24 | 24 weeks | No |
Secondary | Change From Baseline in CD4 Cell Count at Week 24 | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) | Baseline and Week 24 | No |
Secondary | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 48 weeks | Yes |
Secondary | Number of Patients With Serious CAEs at 48 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 48 weeks | Yes |
Secondary | Number of Patients With Drug-related CAEs at 48 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 48 weeks | Yes |
Secondary | Number of Patients With Serious Drug-related CAEs at 48 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. | 48 weeks | Yes |
Secondary | Number of Patients That Died by 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients That Discontinued With CAEs at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 48 weeks | Yes |
Secondary | Number of Patients With Drug-related LAEs at 48 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 48 weeks | Yes |
Secondary | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | 48 weeks | Yes | |
Secondary | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 96 weeks | Yes |
Secondary | Number of Patients With Serious CAEs at 96 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 96 weeks | Yes |
Secondary | Number of Patients With Drug-related CAEs at 96 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 96 weeks | Yes |
Secondary | Number of Patients With Serious Drug-related CAEs at 96 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. | 96 weeks | Yes |
Secondary | Number of Patients That Died by 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients That Discontinued With CAEs at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 96 weeks | Yes |
Secondary | Number of Patients With Drug-related LAEs at 96 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 96 weeks | Yes |
Secondary | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | 96 weeks | Yes | |
Secondary | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 168 weeks | Yes |
Secondary | Number of Patients With Serious CAEs at 168 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 168 weeks | Yes |
Secondary | Number of Patients With Drug-related CAEs at 168 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 168 weeks | Yes |
Secondary | Number of Patients With Serious Drug-related CAEs at 168 Weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. | 168 weeks | Yes |
Secondary | Number of Patients That Died by 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients That Discontinued With CAEs at 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 168 weeks | Yes |
Secondary | Number of Patients With Serious LAEs at 168 Weeks | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 168 weeks | Yes |
Secondary | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | 168 weeks | Yes | |
Secondary | Number of Patients With Drug-related LAEs at 168 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 168 weeks | Yes |
Secondary | Number of Patients With Serious Drug-related LAEs at 168 Weeks | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 168 weeks | Yes |
Secondary | Number of Patients Discontinued With LAEs at 168 Weeks | 168 weeks | Yes |
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