|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Condition: |
HIV Infections |
| Interventions: |
Drug: raltegravir potassium Drug: Comparator: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Phase III; First Patient In: 22-Mar-2006; Last Patient Last Visit for Week 48: 03-Aug-2007 63 sites (Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, and Thailand), 61 of which randomized patients. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria. |
| Description | |
|---|---|
| Raltegravir 400 mg b.i.d. Plus OBT | No text entered. |
| Placebo Plus OBT | No text entered. |
| Raltegravir 400 mg b.i.d. Plus OBT | Placebo Plus OBT | |
|---|---|---|
| STARTED | 234 | 118 |
| Treated | 232 | 118 |
| Continuing in Double-Blind | 193 | 50 |
| COMPLETED | 193[1] | 50 |
| NOT COMPLETED | 41 | 68 |
| Never Treated | 2 | 0 |
| Adverse Event | 1 | 1 |
| Death | 3 | 3 |
| Lack of Efficacy | 0 | 2 |
| Lost to Follow-up | 1 | 1 |
| Withdrawal by Subject | 1 | 1 |
| Entered Virological Failure Phase | 33 | 60 |
| [1] | Does not include patients whom entered the open-label post virological |
|---|
Baseline Characteristics
| Description | |
|---|---|
| Raltegravir 400 mg b.i.d. Plus OBT | No text entered. |
| Placebo Plus OBT | No text entered. |
| Raltegravir 400 mg b.i.d. Plus OBT | Placebo Plus OBT | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
232 | 118 | 350 |
|
Age [units: Years] Mean ( Full Range ) |
46.1 ( 16 to 74 ) |
43.7 ( 19 to 64 ) |
45.3 ( 16 to 74 ) |
|
Gender [units: participants] |
|||
| Female | 37 | 15 | 52 |
| Male | 195 | 103 | 298 |
|
Race/Ethnicity, Customized [units: participants] |
|||
| White | 174 | 96 | 270 |
| Black | 18 | 5 | 23 |
| Asian | 14 | 5 | 19 |
| Hispanic | 6 | 1 | 7 |
| Other | 20 | 11 | 31 |
|
Cluster of Differentiation 4 (CD4) Cell Count [units: cells/mm^3] Mean ( Full Range ) |
156 ( 1 to 792 ) |
153 ( 3 to 759 ) |
155 ( 1 to 792 ) |
|
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) [units: copies/mL] Geometric Mean ( Full Range ) |
40519 ( 441 to 750000 ) |
31828 ( 200 to 750000 ) |
37352 ( 200 to 750000 ) |
Outcome Measures
| 1. Primary: | Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16 [ 16 Weeks ] |
| 2. Secondary: | Change From Baseline in HIV RNA at Week 16 [ Baseline and Week 16 ] |
| 3. Secondary: | Change From Baseline in HIV RNA at Week 48 [ Baseline and Week 48 ] |
| 4. Secondary: | Change From Baseline in CD4 Cell Count at Week 16 [ Baseline and Week 16 ] |
| 5. Secondary: | Change From Baseline in CD4 Cell Count at Week 48 [ Baseline and Week 48 ] |
| 6. Other Pre-specified: | Proportion of Patients Achieving HIV RNA <50 Copies/mL at Week 48 [ 48 weeks ] |
