Phase 3
Completed N=352
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
Source: ClinicalTrials.gov NCT00293267 ↗Enrolled (actual)
352
Serious AEs
40.9%
Results posted
Sep 2009
Primary outcomePrimary: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 — 77.7; 41.0 Percentage of Participants
Summary
This study will investigate the safety and efficacy of raltegravir as a therapy for 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 |
77.7; 41.0 | — |
| PRIMARY Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48 |
73.6; 36.4 | — |
| PRIMARY Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL |
57.3; 25.6 | — |
| PRIMARY Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL |
45.3; 20.3 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16 |
61.6; 33.3 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48 |
64.5; 31.4 | — |
| SECONDARY Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL |
53.4; 25.6 | — |
| SECONDARY Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL |
42.2; 18.6 | — |
| SECONDARY Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response |
47.4; 24.6 | — |
| SECONDARY Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16 |
-1.85; -0.78 | — |
| SECONDARY Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48 |
-1.67; -0.68 | — |
| SECONDARY Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL) |
-1.44; -0.51 | — |
| SECONDARY Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL) |
-1.24; -0.45 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16 |
82.7; 31.3 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 |
120.2; 49.4 | — |
| SECONDARY Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3) |
170.9; 71.03 | — |
| SECONDARY Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3) |
193.6; 68.2 | — |
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 is less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
Data sourced from ClinicalTrials.gov (NCT00293267). 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.