Multicenter, Safety Study Of Maraviroc

NCT00478231 | Completed Phase 3 Results

• 1 other identifier: A4001063
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Acquired Immunodeficiency Syndrome; HIV Infection

Keywords

Multicenter; Open Label; Non-Comparative Safety Study Of Maraviroc; Treatment Experienced

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

  Baseline to 30 days post-week 96 or early termination (ET)

• Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities

  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.

  Baseline to 30 days post-week 96 or ET

• Number of Participants With Treatment Emergent Malignancies

  Baseline to 30 days post-week 96 or ET

• Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections

  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.

  Baseline to 30 days post-week 96 or ET

• Number of Participants With Laboratory Test Abnormalities

  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.

  Baseline to 30 days post-week 96 or ET

Secondary Outcomes (8)

• Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)

  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)

• Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT

• Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT

• 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

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT

• 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

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT

Other Outcomes (3)

• Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT

• Time to Virologic Failure (VF)

  Baseline to Week 96 or EOT

• Number of Participants With Genotype Resistance

  Baseline through Week 96

Study Arms (1)

1

EXPERIMENTAL

Drug: Maraviroc

Interventions

Maraviroc DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (16)

Pfizer Investigational Site

Salvador, Estado de Bahia, 40110-160, Brazil

Location

Pfizer Investigational Site

Brasília, Federal District, 70351-580, Brazil

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80240-280, Brazil

Location

Pfizer Investigational Site

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Pfizer Investigational Site

Florianópolis, Santa Catarina, 88025-301, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13059-900, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13083-887, Brazil

Location

Pfizer Investigational Site

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Pfizer Investigational Site

Santo André, São Paulo, 09060-650, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01246-900, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01307-001, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04040-002, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04121-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04231-030, Brazil

Location

Related Publications (1)

• 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.

  PMID: 23731330 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 9, 2011
• Results First Posted: August 8, 2011

Record last verified: 2011-09

Locations

BR (16)