| February 15, 2006 |
| October 12, 2009 |
| February 2006 |
| December 2008 (final data collection date for primary outcome measure) |
| Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ] |
| Proportion of patients achieving HIV RNA <400 copies/mL at Weeks 24; safety and tolerability assessed by review of the accumulated safety data. |
| Complete list of historical versions of study NCT00293254 on ClinicalTrials.gov Archive Site |
- Change From Baseline in HIV RNA at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
- Change From Baseline in HIV RNA at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
|
| At Week 24 and Week 48: (a) Proportion of patients with virologic response at week 24; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity at Week 48. |
| |
| A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies |
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug |
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
| HIV Infections |
- Drug: Comparator: raltegravir potassium
- Drug: Comparator: placebo
|
- Experimental: raltegravir potassium
- Placebo Comparator: Placebo
|
- Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54.
- Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65.
|
| |
| Active, not recruiting |
| 351 |
| June 2011 |
| December 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient must be HIV positive with HIV RNA values that are within ranges required by the study
- Patient must have documented failure of certain antiretroviral therapy
- Patient must be on the same antiretroviral therapy for at least the past two months
Exclusion Criteria:
- Patient less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
|
| Both |
| 16 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00293254 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2005_097, MK0518-019 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |
