A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
Full description
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.
Enrollment
Sex
Ages
Volunteers
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 is less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
Trial design
Primary purpose
Allocation
Interventional model
Masking
352 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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