Multicenter, Safety Study Of Maraviroc

HIV Infection Clinical Trial

Official title:

A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478231
• Other study ID #: A4001063
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2007
• Last updated: September 1, 2011
• Start date: July 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Ethics Committee (CONEP)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Brasilia	DF
Brazil	Pfizer Investigational Site	Campinas	SP
Brazil	Pfizer Investigational Site	Campinas	SP
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Florianopolis	SC
Brazil	Pfizer Investigational Site	Nova Iguaçu	RJ
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Ribeirao Preto	SP
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	Santo Andre	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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	Yes
Primary	Number of Participants With Treatment Emergent Malignancies		Baseline to 30 days post-week 96 or ET	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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)	No
Secondary	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	No
Secondary	Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification	Below limit of quantification was defined as less than 400 copies/milliliter (mL)	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT	No
Secondary	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	No
Secondary	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	No
Secondary	Change From Baseline in CD4 Percent 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	No
Secondary	Change From Baseline in CD8 Percent 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	No
Secondary	Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status	Virus tropism was done by the Monogram Biosciences Trofile assay.	Time of virologic failure (VF) and Week 96 or EOT	No

External Links

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