Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
This study has been completed.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098748
First received: December 7, 2004
Last updated: November 19, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: March 25, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
HIV Infections |
| Interventions: |
Drug: Optimized Background Therapy (OBT) Drug: maraviroc (UK-427,857) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Maraviroc QD | Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening. |
| Maraviroc BID | Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening. |
| Placebo | Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening. |
Participant Flow for 3 periods
Period 1: Assigned to Study Treatment
| Maraviroc QD | Maraviroc BID | Placebo | |
|---|---|---|---|
| STARTED | 63 | 63 | 64 |
| COMPLETED | 63 | 61 | 62 |
| NOT COMPLETED | 0 | 2 | 2 |
| Randomized, but not treated | 0 | 2 | 2 |
Period 2: Received Study Treatment
| Maraviroc QD | Maraviroc BID | Placebo | |
|---|---|---|---|
| STARTED | 63 | 61 [1] | 62 [2] |
| Dual-tropic Subjects by Phenotype Assay | 57 [3] | 52 | 58 |
| COMPLETED | 15 | 25 | 18 |
| NOT COMPLETED | 48 | 36 | 44 |
| Death | 2 | 1 | 2 |
| Adverse Event | 1 | 2 | 5 |
| Lack of Efficacy | 40 | 27 | 27 |
| Unspecified | 2 | 2 | 6 |
| Subject defaulted | 3 | 4 | 4 |
| [1] | Due to 1 placebo subject switched to maraviroc BID, BID = 62 subjects in Adverse event tables. |
|---|---|
| [2] | Due to 1 placebo subject switched to maraviroc BID, Placebo = 61 subjects in Adverse event tables. |
| [3] | Dual-tropic: Virus capable of using both CCR5 and CXCR4 coreceptors for cell entry. |
Period 3: Continued on Open-Label Treatment
| Maraviroc QD | Maraviroc BID | Placebo | |
|---|---|---|---|
| STARTED | 15 | 25 | 0 [1] |
| COMPLETED | 7 | 10 | 0 |
| NOT COMPLETED | 8 | 15 | 0 |
| Adverse Event | 0 | 1 | 0 |
| Lack of Efficacy | 1 | 2 | 0 |
| Other reason includes protocol violation | 6 | 7 | 0 |
| Lost to Follow-up | 1 | 1 | 0 |
| Withdrawal by Subject | 0 | 4 | 0 |
| [1] | Placebo group not offered open-label maraviroc due to study not reaching primary endpoint at Week 24 |
|---|
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Maraviroc QD | Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening. |
| Maraviroc BID | Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening. |
| Placebo | Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening. |
| Total | Total of all reporting groups |
Baseline Measures
| Maraviroc QD | Maraviroc BID | Placebo | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
63 | 61 | 62 | 186 |
|
Age, Customized
[units: participants] |
||||
| <18 years | 2 | 2 | 0 | 4 |
| Between 18 and 24 years | 1 | 1 | 1 | 3 |
| Between 25 and 34 years | 2 | 3 | 2 | 7 |
| Between 35 and 44 years | 30 | 31 | 31 | 92 |
| Between 45 and 54 years | 25 | 21 | 20 | 66 |
| Between 55 and 64 years | 3 | 3 | 7 | 13 |
| ≥65 years | 0 | 0 | 1 | 1 |
|
Age
[units: years] Mean ( Full Range ) |
42.7
( 16 to 59 ) |
42.5
( 16 to 62 ) |
44.6
( 23 to 65 ) |
43.3
( 16 to 65 ) |
|
Gender
[units: participants] |
||||
| Female | 10 | 6 | 9 | 25 |
| Male | 53 | 55 | 53 | 161 |
Outcome Measures
| 1. Primary: | Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA]) [ Time Frame: Baseline to Week 24 and Week 48 ] |
| 2. Secondary: | Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL [ Time Frame: Week 24, Week 48 ] |
| 3. Secondary: | Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels [ Time Frame: Baseline, Week 24, Week 48 ] |
| 4. Secondary: | Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels [ Time Frame: Baseline, Week 24, Week 48 ] |
| 5. Secondary: | Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL [ Time Frame: Baseline, Week 24, Week 48 ] |
| 6. Secondary: | Change From Baseline in CD4 Cell Count [ Time Frame: Baseline to Week 24 and Week 48 ] |
| 7. Secondary: | Change From Baseline in CD8 Cell Count [ Time Frame: Baseline to Week 24 and Week 48 ] |
| 8. Secondary: | Time (50% Quartile Point Estimate) to Virologic Failure [ Time Frame: Day 1 through Week 24 and through Week 48 ] |
| 9. Secondary: | Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA [ Time Frame: Baseline to Week 24 and Week 48 ] |
| 10. Secondary: | Number of Subjects Per Genotype and Phenotype at Baseline and at Time of Failure [ Time Frame: Baseline through Week 48 ] |
| 11. Secondary: | Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24) [ Time Frame: Screening through Week 24 ] |
| 12. Secondary: | Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48) [ Time Frame: Screening through Week 48 ] |
| 13. Secondary: | Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening [ Time Frame: Screening, Week 24 ] |
| 14. Secondary: | Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening [ Time Frame: Screening, Week48 ] |
| 15. Secondary: | Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24) [ Time Frame: Baseline through Week 24 ] |
| 16. Secondary: | Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48) [ Time Frame: Baseline through Week 48 ] |