Phase 3
Completed N=209
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
Source: ClinicalTrials.gov NCT00764946 ↗Enrolled (actual)
209
Serious AEs
10.7%
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 — 44; 43; 11; 16 Participants
Summary
A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
44; 43; 11; 16; 18; 5 | — |
| PRIMARY Number of Participants With One or More Adverse Events |
55; 40; 12; 23; 13; 6 | — |
| PRIMARY Number of Participants Who Discontinued Due to an Adverse Event |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 |
51; 50; 12; 17; 18; 5 | — |
| SECONDARY Mean Change From Baseline to Week 48 in HIV RNA |
-1.62; -1.16; -2.49; -1.52; -2.21; -1.66 | — |
| SECONDARY Mean Change From Baseline to Week 48 in CD4 Cell Count |
141.0; 62.3; 208.8; 113.1; 69.2; 164.4 | — |
| SECONDARY Number of Participants Without Loss of Virologic Response |
48; 49; 11; 16; 17; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is HIV positive
- Patient agrees to use (or have their partner use) birth control as defined by the study doctor
Exclusion Criteria
- If female, pregnant or breastfeeding
- Patient has used an investigational agent in the last 30 days
- Patient has acute hepatitis
- Patient has received MK0518 (raltegravir) before
- Patient has used another experimental HIV-integrase inhibitor
Data sourced from ClinicalTrials.gov (NCT00764946). 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.