| March 2, 2007 |
| September 30, 2009 |
| May 2007 |
| April 2009 (final data collection date for primary outcome measure) |
| proportion of patients with plasma HIV RNA < 50 copies/mL at Week 24; safety and tolerability at week 24; change from baseline in key lipids at Week 12. [ Time Frame: Weeks 12 & 24 ] [ Designated as safety issue: Yes ] |
| HIV RNA at Week 24; safety and tolerability at week 24; change from baseline in key lipids at Week 12. |
| Complete list of historical versions of study NCT00443703 on ClinicalTrials.gov Archive Site |
| Additional HIV RNA analysis and CD4 cell counts at Week 24 and at Week 48; safety and tolerability at week 48; change from baseline in key lipids at Week 24 and 48. [ Time Frame: Weeks 24 & 48 ] [ Designated as safety issue: Yes ] |
| Additional HIV RNA analysis and CD4 cell counts at Week 24 and at Week 48; safety and tolerability at week 48; change from baseline in key lipids at Week 24 and 48. |
| |
| MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen |
| A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A |
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| HIV Infection |
- Drug: Comparator: raltegravir
- Drug: Comparator: lopinavir (+) ritonavir
- Drug: Comparator: placebo
- Drug: Comparator: placebo (unspecified)
|
- Experimental: Arm 1
- Active Comparator: Arm 2
|
| |
| |
| Terminated |
| 340 |
| May 2009 |
| April 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient is at least 18 years of age. Patient is HIV positive
- Patient has documented HIV RNA <50 copies/mL for at least 3 months while on a KALETRA based regimen
- Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
- Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion Criteria:
- Patient is or plans to become pregnant, or nursing a child
- Patient plans to donate eggs or impregnate/donate sperm
- Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
- Patient is currently receiving a second protease inhibitor in addition to KALETRA
- Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
- Patient has used another experimental HIV-integrase inhibitor
- Patient has a current (active) diagnosis of acute hepatitis due to any cause
- Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00443703 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_507, MK0518-032 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| September 2009 |
