Acquired Immunodeficiency Syndrome, HIV Infection
Conditions
Keywords
Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc, Treatment Experienced
Brief summary
To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.
Interventions
DRUGMaraviroc
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.
Sponsors
Pfizer
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Malignancies | Baseline to 30 days post-week 96 or ET | — |
| Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Baseline to 30 days post-week 96 or ET | 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 | Baseline to 30 days post-week 96 or ET | 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. |
| Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to 30 days post-week 96 or early termination (ET) | 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 | Baseline to 30 days post-week 96 or ET | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status | Time of virologic failure (VF) and Week 96 or EOT | Virus tropism was done by the Monogram Biosciences Trofile assay. |
| 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 | — |
| 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) | — |
| 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 | — |
| Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT | 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 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/ml\]). |
| Number of Participants With Genotype Resistance | Baseline through Week 96 | Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI). |
| Time to Virologic Failure (VF) | Baseline to Week 96 or EOT | Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification. |
Countries
Brazil
Participant flow
Pre-assignment details
A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 206 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Death | 7 |
| Overall Study | Lack of Efficacy | 47 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Other | 9 |
| Overall Study | Randomized, not treated | 3 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Maraviroc |
|---|---|
| Age Continuous | 43.2 Years STANDARD_DEVIATION 7.6 |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 185 / 206 |
| serious Total, serious adverse events | 34 / 206 |
Outcome results
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.
Time frame: Baseline to 30 days post-week 96 or ET
Population: The safety analysis set composed of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Cerebral toxoplasmosis | 2 Participants |
| Maraviroc | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Disseminated cryptococcosis | 1 Participants |
| Maraviroc | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Oesophageal candidiasis | 3 Participants |
| Maraviroc | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Pneumocystis jiroveci pneumonia | 3 Participants |
| Maraviroc | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Leukoencephalopathy | 1 Participants |
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.
Time frame: Baseline to 30 days post-week 96 or ET
Population: The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Alanine aminotransferase (ALT) | 1 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Aspartate aminotransferase (AST) | 0 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Absolute neutrophil count (ANC) | 4 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Alkaline phosphatase | 0 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Gamma-glutamyl transpeptidase (GGT) | 8 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Alanine aminotransferase (ALT) | 0 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Aspartate aminotransferase (AST) | 4 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Absolute neutrophil count (ANC) | 7 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Alkaline phosphatase | 1 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Gamma-glutamyl transpeptidase (GGT) | 15 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Hyperbilirubinemia | 17 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Hyperuricemia | 3 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Lipase (n= 101) | 8 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Platelets | 3 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Potassium (Hyperkalemia) | 0 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3: Serum amylase | 12 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Hyperbilirubinemia | 6 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Hyperuricemia | 1 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Lipase (n= 101) | 2 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Platelets | 0 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Potassium (Hyperkalemia) | 2 Participants |
| Maraviroc | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 4: Serum amylase | 1 Participants |
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.
Time frame: Baseline to 30 days post-week 96 or early termination (ET)
Population: The safety analysis set composed of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | Grade 3 AEs | 40 Participants |
| Maraviroc | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | Grade 4 AEs | 9 Participants |
| Maraviroc | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 34 Participants |
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.
Time frame: Baseline to 30 days post-week 96 or ET
Population: The safety analysis set composed of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent neutrophils (>1.2*ULN) (n= 1) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Absolute basophils (>1.2*ULN) | 10 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent basophils (>1.2*ULN) (n= 1) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Absolute eosinophils (>1.2*ULN) | 32 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Total protein (<0.8*LLN) | 1 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Total protein (>1.2*ULN) | 19 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Albumin (<0.8*LLN) | 3 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Hematocrit (<0.8*LLN) | 13 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Red blood cell count (<0.8*LLN) | 35 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | White blood cell count (<0.6*LLN) | 7 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | White blood cell count (>1.5*ULN) | 4 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Absolute lymphocytes (<0.8*LLN) | 12 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Absolute lymphocytes (>1.2*ULN) | 60 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent lymphocytes (<0.8*LLN) (n= 1) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent lymphocytes (>1.2*ULN) (n= 1) | 1 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent neutrophils (<0.8*LLN) (n= 1) | 1 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent eosinophils (>1.2*ULN) (n= 1) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Absolute monocytes (>1.2*ULN) | 25 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Percent monocytes (>1.2*ULN) (n= 1) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin (>1.5*ULN) | 67 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Indirect bilirubin (>1.5*ULN) | 25 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Lactose dehydrogenase (LDH) (>3.0*ULN) | 1 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Albumin (>1.2*ULN) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Blood urea nitrogen (BUN) (>1.3*ULN) | 7 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Cholesterol (>1.3*ULN) | 26 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | High density lipoprotein cholesterol (<0.8*LLN) | 115 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Low density lipoprotein cholesterol (>1.2*ULN) | 101 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Triglycerides (>1.3*ULN) | 145 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Calcium (<0.9*LLN) | 6 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Calcium (>1.1*ULN) | 0 Participants |
| Maraviroc | Number of Participants With Laboratory Test Abnormalities | Creatine kinase (CK) (>2.0*ULN) | 50 Participants |
Primary
Number of Participants With Treatment Emergent Malignancies
Time frame: Baseline to 30 days post-week 96 or ET
Population: The safety analysis set composed of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Treatment Emergent Malignancies | Carcinoma in situ | 1 Participants |
| Maraviroc | Number of Participants With Treatment Emergent Malignancies | Hodgkin's disease | 1 Participants |
| Maraviroc | Number of Participants With Treatment Emergent Malignancies | Intestinal T-cell lymphoma | 1 Participants |
| Maraviroc | Number of Participants With Treatment Emergent Malignancies | Neoplasm of appendix | 1 Participants |
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
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 84 (n= 124) | 5.3 Percent CD4 | Standard Deviation 5.2 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 96 or EOT (n= 107) | 6.6 Percent CD4 | Standard Deviation 5.1 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at LOCF (n= 201) | 4.9 Percent CD4 | Standard Deviation 5.3 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline | 12.2 Percent CD4 | Standard Deviation 7.5 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 4 (n= 190) | 1.8 Percent CD4 | Standard Deviation 3.4 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 8 (n= 190) | 1.3 Percent CD4 | Standard Deviation 3.2 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 12 (n= 186) | 2.1 Percent CD4 | Standard Deviation 4.4 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 24 (n= 184) | 2.9 Percent CD4 | Standard Deviation 3.7 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 36 (n= 165) | 3.6 Percent CD4 | Standard Deviation 3.9 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 48 (n= 154) | 4.3 Percent CD4 | Standard Deviation 4.1 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 60 (n= 134) | 4.5 Percent CD4 | Standard Deviation 4.5 |
| Maraviroc | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 72 (n= 129) | 5.2 Percent CD4 | Standard Deviation 4.3 |
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
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline | 59.8 Percent CD8 | Standard Deviation 13.1 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 4 (n= 190) | 0.4 Percent CD8 | Standard Deviation 6.1 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 8 (n= 190) | 0.9 Percent CD8 | Standard Deviation 7.3 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 12 (n= 186) | -0.1 Percent CD8 | Standard Deviation 8.2 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 24 (n= 185) | -2.5 Percent CD8 | Standard Deviation 8.3 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 36 (n= 165) | -3.6 Percent CD8 | Standard Deviation 8.6 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 48 (n= 155) | -4.3 Percent CD8 | Standard Deviation 9.9 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 60 (n= 135) | -4.7 Percent CD8 | Standard Deviation 10.4 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 72 (n= 130) | -6.1 Percent CD8 | Standard Deviation 10.9 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 84 (n= 124) | -6.8 Percent CD8 | Standard Deviation 10.3 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at Week 96 or EOT (n= 107) | -7.7 Percent CD8 | Standard Deviation 10.7 |
| Maraviroc | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change at LOCF (n= 201) | -5.4 Percent CD8 | Standard Deviation 10.6 |
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
Population: The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | 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 | Change at Week 8 (n= 190) | 110.0 cells per microliter (cells/µL) | Standard Deviation 95.2 |
| Maraviroc | 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 | Change at Week 12 (n= 186) | 132.1 cells per microliter (cells/µL) | Standard Deviation 164.1 |
| Maraviroc | 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 | Change at Week 24 (n= 184) | 137.3 cells per microliter (cells/µL) | Standard Deviation 115 |
| Maraviroc | 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 | Change at Week 36 (n= 165) | 157.8 cells per microliter (cells/µL) | Standard Deviation 128.4 |
| Maraviroc | 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 | 215.6 cells per microliter (cells/µL) | Standard Deviation 179.9 |
| Maraviroc | 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 | Change at Week 4 (n= 190) | 93.5 cells per microliter (cells/µL) | Standard Deviation 96.7 |
| Maraviroc | 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 | Change at Week 48 (n= 154) | 172.2 cells per microliter (cells/µL) | Standard Deviation 124 |
| Maraviroc | 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 | Change at Week 60 (n= 134) | 187.2 cells per microliter (cells/µL) | Standard Deviation 140.4 |
| Maraviroc | 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 | Change at Week 72 (n= 129) | 199.8 cells per microliter (cells/µL) | Standard Deviation 161 |
| Maraviroc | 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 | Change at Week 84 (n= 124) | 198.2 cells per microliter (cells/µL) | Standard Deviation 177.3 |
| Maraviroc | 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 | Change at Week 96 or EOT (n= 107) | 225.2 cells per microliter (cells/µL) | Standard Deviation 175.3 |
| Maraviroc | 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 | Change at LOCF (n= 201) | 174.1 cells per microliter (cells/µL) | Standard Deviation 168.5 |
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
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | 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 | 1016.4 cells/µL | Standard Deviation 676.3 |
| Maraviroc | 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 | Change at Week 4 (n= 190) | 387.3 cells/µL | Standard Deviation 597 |
| Maraviroc | 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 | Change at Week 8 (n= 190) | 518.3 cells/µL | Standard Deviation 666.4 |
| Maraviroc | 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 | Change at Week 12 (n= 186) | 507.2 cells/µL | Standard Deviation 685.6 |
| Maraviroc | 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 | Change at Week 24 (n= 185) | 358.1 cells/µL | Standard Deviation 577.2 |
| Maraviroc | 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 | Change at Week 36 (n= 165) | 352.3 cells/µL | Standard Deviation 545.3 |
| Maraviroc | 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 | Change at Week 48 (n= 155) | 348.6 cells/µL | Standard Deviation 591 |
| Maraviroc | 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 | Change at Week 60 (n= 135) | 349.1 cells/µL | Standard Deviation 566.7 |
| Maraviroc | 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 | Change at Week 72 (n= 130) | 272.4 cells/µL | Standard Deviation 594.8 |
| Maraviroc | 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 | Change at Week 84 (n= 124) | 246.7 cells/µL | Standard Deviation 567.3 |
| Maraviroc | 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 | Change at Week 96 or EOT (n= 107) | 214.5 cells/µL | Standard Deviation 593.2 |
| Maraviroc | 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 | Change at LOCF (n= 201) | 223.0 cells/µL | Standard Deviation 562 |
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 frame: Time of virologic failure (VF) and Week 96 or EOT
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status | VF X4 (n= 134) | 7 Participants |
| Maraviroc | Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status | EOT X4 (n= 146) | 8 Participants |
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)
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
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Baseline | 2.4 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 4 (n= 202) | 29.7 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 8 (n= 196) | 43.9 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 12 (n= 190) | 42.6 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 24 (n= 185) | 41.1 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 36 (n= 171) | 47.4 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 48 (n= 158) | 41.1 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 60 (n= 141) | 36.2 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 72 (n= 137) | 24.8 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 84 (n= 125) | 23.2 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Week 96 or EOT (n= 109) | 33.9 Percentage of participants |
| Maraviroc | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | LOCF (n= 206) | 26.7 Percentage of participants |
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)
Population: The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 4 (n= 202) | 78.7 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 8 (n= 196) | 78.6 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 12 (n= 190) | 80.5 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 24 (n= 185) | 79.5 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 36 (n= 171) | 83.6 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 48 (n= 158) | 82.3 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 60 (n= 141) | 84.4 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 72 (n= 137) | 81.0 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 84 (n= 125) | 82.4 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 96 or EOT (n= 109) | 89.9 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | LOCF (n= 206) | 76.2 Percentage of participants |
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
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 84 (n= 125) | 71.2 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 4 (n= 202) | 67.8 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 8 (n= 196) | 68.9 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 12 (n= 190) | 71.1 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 24 (n= 185) | 68.6 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 36 (n= 171) | 69.0 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 48 (n= 158) | 70.3 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 60 (n= 141) | 70.2 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 72 (n= 137) | 64.2 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | Week 96 or EOT (n= 109) | 72.5 Percentage of participants |
| Maraviroc | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | LOCF (n= 206) | 61.2 Percentage of participants |
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
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/ml\]).
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
Population: The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | 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 | Change at week 8 (n= 196) | -1.5 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 12 (n= 190) | -1.6 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 24 (n= 185) | -1.6 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 36 (n= 171) | -1.6 log 10 copies/ml | Standard Deviation 1 |
| Maraviroc | 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 | Change at week 48 (n= 158) | -1.6 log 10 copies/ml | Standard Deviation 1 |
| Maraviroc | 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 | Baseline | 4.8 log 10 copies/ml | Standard Deviation 0.9 |
| Maraviroc | 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 | Change at week 4 (n= 202) | -1.5 log 10 copies/ml | Standard Deviation 1 |
| Maraviroc | 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 | Change at week 60 (n= 141) | -1.6 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 72 (n= 137) | -1.4 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 84 (n= 125) | -1.5 log 10 copies/ml | Standard Deviation 1.1 |
| Maraviroc | 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 | Change at week 96 or EOT (n= 109) | -1.7 log 10 copies/ml | Standard Deviation 1 |
| Maraviroc | 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 | Change at LOCF (n= 206) | -1.4 log 10 copies/ml | Standard Deviation 1.1 |
Other Pre-specified
Number of Participants With Genotype Resistance
Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).
Time frame: Baseline through Week 96
Population: FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Genotype Resistance | VF: NRTI | 0 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: NNRTI | 0 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: PI | 16 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: NRTI and NNRTI | 0 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: NRTI and PI | 32 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: NNRTI and PI | 7 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: NRTI and NNRTI and PI | 64 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: no NRTI, no NNRTI and no PI | 0 Participants |
| Maraviroc | Number of Participants With Genotype Resistance | VF: no test result data | 48 Participants |
Other Pre-specified
Time to Virologic Failure (VF)
Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.
Time frame: Baseline to Week 96 or EOT
Population: The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Maraviroc | Time to Virologic Failure (VF) | 255.0 Days |