A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)
- Registration Number
- NCT01213316
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load \< 50 copies/mL after 48 weeks of treatment with Raltegravir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Overall Participants Raltegravir HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Aging Participants Raltegravir HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort).
- Primary Outcome Measures
Name Time Method Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks The percentage of participants with an HIV-1 viral load \<50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks The percentage of aging participants (\>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load \<50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
- Secondary Outcome Measures
Name Time Method Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment Baseline and 96 weeks Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment Baseline and 96 weeks The percentage of participants with an HIV-1 viral load \<50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.
HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment Baseline and 96 weeks The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.
HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (\>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks Mean CD4+ T-cell counts were determined in aging participants (\>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.
Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (\>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment Baseline and 48 weeks Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (\>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: \<1%; moderate: 1-5%; high: 5-10%; and very high: \>10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Percentage of Aging Participants With Concomitant Diseases at Baseline Baseline The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Percentage of Aging Participants Taking Concomitant Medications at Baseline Baseline The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.