Multicenter, Safety Study Of Maraviroc - Full Text View

Purpose

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

Condition	Intervention	Phase
Acquired Immunodeficiency Syndrome 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 Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	209
Study Start Date:	July 2007
Study Completion Date:	September 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478231

Locations

Brazil
Pfizer Investigational Site
Salvador, BA, Brazil, 40110-160
Pfizer Investigational Site
Brasilia, DF, Brazil, 70351-580
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30130-100
Pfizer Investigational Site
Curitiba, PR, Brazil, 80240-280
Pfizer Investigational Site
Nova Iguaçu, RJ, Brazil, 26030-380
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90110-270
Pfizer Investigational Site
Florianopolis, SC, Brazil, 88025-301
Pfizer Investigational Site
Campinas, SP, Brazil, 13083-887
Pfizer Investigational Site
Campinas, SP, Brazil, 13059-900
Pfizer Investigational Site
Ribeirao Preto, SP, Brazil, 14048900
Pfizer Investigational Site
Santo Andre, SP, Brazil, 09060-650
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04040-002
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04121-000
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01307-001
Pfizer Investigational Site
São Paulo, SP, Brazil, 04231-030

Sponsors and Collaborators

ViiV Healthcare

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT00478231 History of Changes
Other Study ID Numbers:	A4001063
Study First Received:	May 22, 2007
Results First Received:	July 8, 2011
Last Updated:	September 1, 2011
Health Authority:	Brazil: National Ethics Committee (CONEP)

Keywords provided by ViiV Healthcare:

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

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013