Phase 3
Completed N=1,047
Expanded Access Program for Maraviroc At Multiple Centers
Source: ClinicalTrials.gov NCT00426660 ↗Enrolled (actual)
1,047
Serious AEs
13.5%
Results posted
Oct 2011
Primary outcomePrimary: Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) — 13.2; 2.4; 6.3; 1.6 percentage of participants
Summary
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) |
13.2; 2.4; 6.3; 1.6 | — |
| PRIMARY Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities |
2.17; 2.07; 0.70; 0.39; 0.49; 4.73 | — |
| PRIMARY Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities |
0.79; 0.39; 0.20; 0.00; 0.10; 1.48 | — |
| PRIMARY Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses |
0.1; 0.1; 0.2; 0.1; 0.1; 0.1 | — |
| PRIMARY Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load |
— | — |
| PRIMARY Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts |
— | — |
| PRIMARY Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy |
— | — |
| PRIMARY Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender |
69.6; 73.7 | — |
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race |
68.5; 67.9; 88.9; 85.5 | — |
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age |
100.0; 71.7; 68.6; 82.6 | — |
| PRIMARY Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status |
71.3; 65.0; 64.0; 72.7; 62.7; 63.8 | — |
| SECONDARY Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) |
46.2; 93.8; 93; 93.2; 94; 87.7 | — |
| SECONDARY Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA |
30.8; 90.3; 90.2; 91.2; 91.3; 82.6 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL |
6.7; 3.8; 58.8; 72.7; 78.8; 82.5 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL |
1.7; 0.0; 19.9; 30.1; 43.1; 45.8 | — |
| SECONDARY Change From Baseline in CD4 Cell Count |
28.5; 49.7; 68.9; 94.5; 95.7; 85.9 | — |
| SECONDARY Change From Baseline in CD4 Cell Count Percent |
-1.3; 1.8; 1.6; 1.4; 1.6; 1.9 | — |
| SECONDARY Change From Baseline in CD8 Cell Count |
268.5; 78.2; 205.6; 345.6; 309.4; 259.6 | — |
| SECONDARY Change From Baseline in CD8 Cell Count Percent |
3.0; -1.5; -0.3; 0.4; -0.9; 0.7 | — |
| SECONDARY Median Time to Virologic Failure |
86.5 | — |
| SECONDARY Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure |
43.75; 31.77; 18.75; 3.13; 2.60 | — |
| SECONDARY Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure |
5.73; 0.52; 1.04; 7.29; 1.56; 0.52 | — |
| SECONDARY Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau |
14 | — |
| SECONDARY Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120) |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
- Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
- Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.
Exclusion Criteria
- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
Data sourced from ClinicalTrials.gov (NCT00426660). 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.