Phase 3
Completed N=351
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
Source: ClinicalTrials.gov NCT00293254 ↗Enrolled (actual)
351
Serious AEs
38.4%
Results posted
Sep 2009
Primary outcomePrimary: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 — 77.3; 42.9 Percentage of Participants
Summary
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 |
77.3; 42.9 | — |
| PRIMARY Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48 |
71.1; 37.8 | — |
| PRIMARY Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL |
50.2; 21.0 | — |
| PRIMARY Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL |
45.7; 13.4 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16 |
62.0; 36.1 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48 |
59.6; 34.5 | — |
| SECONDARY Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL |
47.6; 17.6 | — |
| SECONDARY Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL |
41.3; 13.4 | — |
| SECONDARY Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response |
44.3; 17.6 | — |
| SECONDARY Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16 |
-1.92; -1.06 | — |
| SECONDARY Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48 |
-1.75; -0.87 | — |
| SECONDARY Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL) |
-1.37; -0.52 | — |
| SECONDARY Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL) |
-1.31; -0.41 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16 |
85.8; 39.9 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 |
98.4; 39.8 | — |
| SECONDARY Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3) |
157.2; 54.2 | — |
| SECONDARY Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3) |
172.1; 54.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be HIV positive with HIV RNA values that are within ranges required by the study
- Patient must have documented failure of certain antiretroviral therapy
- Patient must be on the same antiretroviral therapy for at least the past two months
Exclusion Criteria
- Patient less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
Data sourced from ClinicalTrials.gov (NCT00293254). 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.