N/A
Completed N=451
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)
Source: ClinicalTrials.gov NCT01213316 ↗Enrolled (actual)
451
Serious AEs
8.0%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment — 50.8; 74.7 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment |
50.8; 74.7 | — |
| PRIMARY Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment |
62.1; 77.5 | — |
| SECONDARY Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment |
43.8; 68.0 | — |
| SECONDARY HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment |
2.90; 1.52 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment |
461.9; 161.7 | — |
| SECONDARY HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment |
2.28; 1.50 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment |
534.4; 63.2 | — |
| SECONDARY Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment |
24.1; 1.1 | — |
| SECONDARY 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 |
9.4; 4.2 | — |
| SECONDARY Percentage of Aging Participants With Concomitant Diseases at Baseline |
93.8 | — |
| SECONDARY Percentage of Aging Participants Taking Concomitant Medications at Baseline |
74.9 | — |
Eligibility Criteria
Inclusion Criteria
The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
- Is a minimum age of 18 years (adults) or 50 years (aging participants);
- Is male or female;
- Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice);
- Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;
- Has any cluster of differentiation (CD4) cell (specialized white blood cell) count upon enrollment on the study.
Exclusion criteria
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
- For which Raltegravir, or its ingredients, are contraindicated;
- Has intolerance to Raltegravir, or its ingredients;
- If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation during the study.
Data sourced from ClinicalTrials.gov (NCT01213316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.