Multicenter, Safety Study Of Maraviroc

• 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.

• 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.

• Secondary endpoints include the following efficacy variables: change in HIV-1 RNA levels from baseline, proportion of subjects achieving HIV-1 RNA levels below the limit of quantification
• CD4 and CD8 cell counts and percent, time to virologic failure, and evolution of resistance to OBT in samples collected at time of virologic failure.
• Change in chemokine co-receptor tropism from screening to time of virologic failure will be reported for all subjects meeting the definition of virologic failure.

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

• Acquired Immunodeficiency Syndrome
• HIV Infection

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.