Phase 3 N=1,047 Treatment

Expanded Access Program for Maraviroc At Multiple Centers

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00426660 ↗

Enrolled (actual)

1,047

Serious AEs

13.5%

Results posted

Oct 2011

Primary outcome: Primary: Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) — 13.2; 2.4; 6.3; 1.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: maraviroc (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: ViiV Healthcare
Primary completion: Jun 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.