Expanded Access Program for Maraviroc At Multiple Centers

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00426660
First received: January 22, 2007
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Advanced HIV Infection
Drug: maraviroc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.


Secondary Outcome Measures:
  • Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]

    Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.

    Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.


  • Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

  • Change From Baseline in CD4 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD4 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD8 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD8 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Median Time to Virologic Failure [ Time Frame: Day 1 up to Week 144 ] [ Designated as safety issue: No ]
    Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.

  • Emergence of Resistance to Maraviroc [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Resistance defined by genotypic changes in the V3 loop of HIV 1 viral envelope glycoprotein 120 [gp 120] and/or the entire gp 120 gene associated with decreased susceptibility to maraviroc for participants who meet the definition of virologic failure during the trial.

  • Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.

  • Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure [ Time Frame: Screening up to Week 144 ] [ Designated as safety issue: No ]
    Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.


Enrollment: 1047
Study Start Date: February 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: maraviroc
The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426660

  Show 330 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00426660     History of Changes
Other Study ID Numbers: A4001050
Study First Received: January 22, 2007
Results First Received: June 2, 2011
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV Infections

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014