N/A
Completed N=482
Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)
Source: ClinicalTrials.gov NCT01048671 ↗Enrolled (actual)
482
Serious AEs
13.8%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir — 44.4; 14.0; 1.3; 15.7 Percentage of participants
Summary
To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir |
44.4; 14.0; 1.3; 15.7; 8.8; 15.7 | — |
| PRIMARY Percentage of Participants Responding to Treatment: All Treated Participants |
94.2; 94.3; 71.2; 87.2 | — |
| PRIMARY Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 |
94.9; 95.4; 77.7; 90.2 | — |
| PRIMARY Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants |
260.58; 47.97; 149.98; 107.53 | — |
| PRIMARY Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 |
285.05; 49.21; 150.87; 106.15 | — |
| SECONDARY Number of Participants With at Least One Adverse Event |
287 | — |
Eligibility Criteria
Inclusion Criteria
- Participant Infected With HIV-1.
- Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
- Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.
Exclusion Criteria
- Participant taking part in a clinical trial to assess raltegravir.
- Participant in whom raltegravir treatment was started more than 30 days ago.
Data sourced from ClinicalTrials.gov (NCT01048671). 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.