Clinical trial NCT00478231: Multicenter, Safety Study Of Maraviroc
Official title: A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acquired Immunodeficiency Syndrome
HIV Infection
Keywords: Multicenter
Open Label
Non-Comparative Safety Study Of Maraviroc
Treatment Experienced
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-05-24
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to 30 days post-week 96 or early termination (ET)
measure: Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities
timeFrame: Baseline to 30 days post-week 96 or ET
measure: Number of Participants With Treatment Emergent Malignancies
timeFrame: Baseline to 30 days post-week 96 or ET
measure: Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections
timeFrame: Baseline to 30 days post-week 96 or ET
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline to 30 days post-week 96 or ET
Secondary outcomes:
measure: Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
timeFrame: 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)
measure: Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: 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
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: 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
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status
timeFrame: Time of virologic failure (VF) and Week 96 or EOT
Other outcomes:
measure: 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
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
measure: Time to Virologic Failure (VF)
timeFrame: Baseline to Week 96 or EOT
measure: Number of Participants With Genotype Resistance
timeFrame: Baseline through Week 96
Locations:
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Brasilia
country: Brazil
facility: Pfizer Investigational Site
state: DF
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Nova Iguaçu
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Florianopolis
country: Brazil
facility: Pfizer Investigational Site
state: SC
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Santo Andre
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.