HIV Infections
Conditions
Keywords
treatment experienced, HIV
Brief summary
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
Interventions
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Remain on present anti-HIV drugs during screening until a new regimen is started. * Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it. * Have an HIV which shows reduced susceptibility to lopinavir. * Are at least 18 years old. * Are not presently ill. * Have not been treated for an opportunistic infection within 30 days of screening. * Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs. * Agree to use an accepted barrier method of birth control. Exclusion: * Female subject is pregnant or lactating. * Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks. * Are taking chemotherapy. * Have a medical problem with their pancreas. * Have been screened for this study within the past 12 weeks. * Appear to be unsuitable in the opinion of the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48 | — |
Countries
Argentina, Brazil, Canada, France, Germany, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
Outcome results
None listed