A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

NCT00426660 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	ViiV Healthcare
Phase	Phase 3
Status	COMPLETED
Enrolment	1047
Start date	2007-02
Completion	2010-06

Conditions

• HIV Infections

Interventions

• maraviroc

Primary outcomes

• Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) — Baseline up to Week 144
  AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
• Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities — Baseline up to Week 144
  Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
• Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities — Baseline up to Week 144
  Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
• Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses — Baseline up to Week 144
  Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
• Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load — Baseline up to Week 144
• Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts — Baseline up to Week 144

Countries

United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Spain, Switzerland, Taiwan, United Kingdom