N/A
N=79
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
HIV-1
Bottom Line
View on ClinicalTrials.gov: NCT00850395 ↗Enrolled (actual)
79
Serious AEs
3.8%
Results posted
Oct 2012
Primary outcome: Primary: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 — -1.10 copies/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- maraviroc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 |
-1.10 | — |
| PRIMARY Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 |
-1.15 | — |
| PRIMARY Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 |
-0.95 | — |
| PRIMARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 |
74.31 | — |
| PRIMARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 |
91.88 | — |
| PRIMARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 |
97.57 | — |
| PRIMARY Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 |
31; 19; 26 | — |
| PRIMARY Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 |
31; 16; 27 | — |
| PRIMARY Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 |
31; 20; 28 | — |
| SECONDARY Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12 |
-4.87; -2.14 | — |
| SECONDARY Number of Participants With Human Immunodeficiency Virus (HIV) Response |
51 | — |
| SECONDARY Physician's Assessment of Efficacy |
15; 42; 14; 1; 1 | — |
| SECONDARY Number of Participants Taking Concomitant Therapy |
1; 1; 2; 2; 1; 0 | — |
Summary
Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.
Eligibility Criteria
Inclusion Criteria
HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
Exclusion Criteria
X4 or D/M tropic virus. Therapy-naive patients.
Data sourced from ClinicalTrials.gov (NCT00850395). 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.