Multicenter, Safety Study Of Maraviroc

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00478231
First received: May 22, 2007
Last updated: September 1, 2011
Last verified: September 2011

May 22, 2007
September 1, 2011
July 2007
August 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to 30 days post-week 96 or early termination (ET) ] [ Designated as safety issue: Yes ]
    AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
  • Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities [ Time Frame: Baseline to 30 days post-week 96 or ET ] [ Designated as safety issue: Yes ]
    Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
  • Number of Participants With Treatment Emergent Malignancies [ Time Frame: Baseline to 30 days post-week 96 or ET ] [ Designated as safety issue: Yes ]
  • Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections [ Time Frame: Baseline to 30 days post-week 96 or ET ] [ Designated as safety issue: Yes ]
    Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: Baseline to 30 days post-week 96 or ET ] [ Designated as safety issue: Yes ]
    Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.
Laboratory test results in all subjects who receive at least one dose of study medication in all study visits.
Complete list of historical versions of study NCT00478231 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT) ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
    Below limit of quantification was defined as less than 400 copies/milliliter (mL)
  • 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 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
  • Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ] [ Designated as safety issue: No ]
  • Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status [ Time Frame: Time of virologic failure (VF) and Week 96 or EOT ] [ Designated as safety issue: No ]
    Virus tropism was done by the Monogram Biosciences Trofile assay.
  • Secondary endpoints include the following efficacy variables: change in HIV-1 RNA levels from baseline, proportion of subjects achieving HIV-1 RNA levels below the limit of quantification
  • CD4 and CD8 cell counts and percent, time to virologic failure, and evolution of resistance to OBT in samples collected at time of virologic failure.
  • Change in chemokine co-receptor tropism from screening to time of virologic failure will be reported for all subjects meeting the definition of virologic failure.
Not Provided
Not Provided
 
Multicenter, Safety Study Of Maraviroc
A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infection
Drug: Maraviroc
Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.
Experimental: 1
Intervention: Drug: Maraviroc
Furtado J, Madruga JV, Bicudo EL, da Eira M, Lopes MI, Netto EM, Santini-Oliveira M, Leite OH, Machado AA, Tupinambas U, de Andrade Neto JL, Lima MP, Pedro Rde J, Miranda AF, Lewi DS, Santos BR, Portsmouth S, Wajsbrot DB, Cassoli LM. Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1203-10. doi: 10.1089/AID.2012.0330. Epub 2013 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
September 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00478231
A4001063
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP