Status:
COMPLETED
A 48-Week, Randomised, Study to Describe the Pharmacokinetic Profile and Durability of Atazanavir-Saquinavir-Ritonavir Once Daily and Describe the Pharmacokinetic Profile of Saquinavir-Ritonavir Using Saquinavir 500mg Formulation: the ASK-500 Study
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on saquinavir require to ...
Detailed Description
BACKGROUND The development of anti-HIV therapy for the treatment of HIV disease has improved the quality of life and survival of many people with HIV. However the treatments do not always work over lo...
Eligibility Criteria
Inclusion
- HIV-1 infected individuals aged 18 years or over On stable antiretroviral therapy for at least three months consisting of nucleoside reverse transcriptase inhibitors and protease inhibitors OR On stable antiretroviral therapy for at least three months consisting of atazanavir-saquinavir-ritonavir Undetectable HIV RNA viral load for past three months
Exclusion
- Individuals receiving on non-nucleoside reverse transcriptase inhibitors within the past three months
- Individuals currently receiving other enzyme inducing agents (as per
- Individuals receiving ritonavir at doses greater than 100 mg bid
- Active AIDS defining illnesses
- Previously documented intolerance or virological failure to saquinavir
- Previously documented intolerance or virological failure to atazanavir
- Patients who are co-infected with Hepatitis B and are likely to require, in their clinician's opinion, HBV nucleoside therapy during the study.
- Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study
- Any current clinical or laboratory parameter of ACTG Grade 4 (except lipids \& CK)
- Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol
- Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol
- Evidence of active opportunistic infection, intercurrent illness, drug toxicity or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen
- Conditions that might interfere with evaluation of the disease under study.
- Conditions/allergies that may compromise the safety of the patient.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00192608
Start Date
November 1 2004
End Date
May 1 2006
Last Update
June 26 2009
Active Locations (1)
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1
St Vincents Hospital
Sydney, New South Wales, Australia, 2010