Phase 3
N=209
Multicenter, Safety Study Of Maraviroc
Acquired Immunodeficiency Syndrome · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00478231 ↗Enrolled (actual)
209
Serious AEs
16.5%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) — 40; 9; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Maraviroc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) |
40; 9; 34 | — |
| PRIMARY Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities |
0; 4; 7; 1; 15; 17 | — |
| PRIMARY Number of Participants With Treatment Emergent Malignancies |
1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections |
2; 1; 3; 3; 1 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
13; 35; 7; 4; 12; 60 | — |
| SECONDARY Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) |
78.7; 78.6; 80.5; 79.5; 83.6; 82.3 | — |
| SECONDARY Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA |
67.8; 68.9; 71.1; 68.6; 69.0; 70.3 | — |
| SECONDARY Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification |
2.4; 29.7; 43.9; 42.6; 41.1; 47.4 | — |
| SECONDARY Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT |
215.6; 93.5; 110.0; 132.1; 137.3; 157.8 | — |
| SECONDARY Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT |
1016.4; 387.3; 518.3; 507.2; 358.1; 352.3 | — |
| SECONDARY Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT |
12.2; 1.8; 1.3; 2.1; 2.9; 3.6 | — |
| SECONDARY Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT |
59.8; 0.4; 0.9; -0.1; -2.5; -3.6 | — |
| SECONDARY Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status |
7; 8 | — |
Summary
To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.
Eligibility Criteria
Inclusion Criteria
- Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
- Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
- Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.
Exclusion Criteria
- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
- Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.
Data sourced from ClinicalTrials.gov (NCT00478231). 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.