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

History of Changes

Results First Received: July 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Acquired Immunodeficiency Syndrome HIV Infection
Intervention:	Drug: Maraviroc

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.

Reporting Groups

	Description
Maraviroc	Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.

Participant Flow: Overall Study

	Maraviroc
STARTED	209
Treated	206
COMPLETED	125
NOT COMPLETED	84
Death	7
Lack of Efficacy	47
Lost to Follow-up	7
Withdrawal by Subject	6
Unspecified	9
Adverse Event	5
Randomized, not treated	3

Baseline Characteristics

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Reporting Groups

	Description
Maraviroc	Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.

Baseline Measures

	Maraviroc
Number of Participants [units: participants]	206
Age [units: Years] Mean ± Standard Deviation	43.2 ± 7.6
Gender [units: Participants]
Female	61
Male	145

Outcome Measures

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1. Primary:

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) ]

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2. Primary:

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 ]

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3. Primary:

Number of Participants With Treatment Emergent Malignancies [ Time Frame: Baseline to 30 days post-week 96 or ET ]

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4. Primary:

Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections [ Time Frame: Baseline to 30 days post-week 96 or ET ]

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5. Primary:

Number of Participants With Laboratory Test Abnormalities [ Time Frame: Baseline to 30 days post-week 96 or ET ]

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6. Secondary:

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) ]

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7. Secondary:

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 ]

Show Outcome Measure 7

8. Secondary:

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 ]

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9. 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 [ 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 ]

Show Outcome Measure 9

10. 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 [ 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 ]

Show Outcome Measure 10

11. Secondary:

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 ]

Show Outcome Measure 11

12. Secondary:

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 ]

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13. Secondary:

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 ]

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14. Other Pre-specified:

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 [ 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 ]

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15. Other Pre-specified:

Time to Virologic Failure (VF) [ Time Frame: Baseline to Week 96 or EOT ]

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16. Other Pre-specified:

Number of Participants With Genotype Resistance [ Time Frame: Baseline through Week 96 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

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)

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