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Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research Hoffmann-La Roche |
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Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00192608 |
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 take 5 tablets twice a day. In an attempt to reduce this number of pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir formulations when given with atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir formulation with atazanavir as HIV therapy.
Condition | Intervention |
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HIV Infections |
Drug: saquinavir 500 formulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Official Title: | 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. |
Estimated Enrollment: | 40 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | May 2006 |
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 long periods, as medications are often difficult to take due to side effects and a large numbers of pills to be taken.
This has lead researchers to look for new ways to treat HIV with medications that require fewer numbers of pills and have fewer side effects.
Atazanavir and saquinavir are two drugs used to treat HIV and come from the same class of drugs known as the protease inhibitors. Atazanavir has the advantage of being taken only once a day. Saquinavir is available in a new formulation (type of pill), which will require fewer numbers of pills to be taken daily.
AIM The purpose of this study is to investigate the use of these two drugs used together with ritonavir as a once daily HIV treatment, which will consist of 6 tablets. Furthermore this study will look at blood drug levels in individuals on atazanavir, saquinavir and ritonavir with and without the new saquinavir formulation to ensure blood levels of these drugs are adequate. For individuals currently on the old saquinavir formulation, this study will also look at blood drug levels before and after changing to the new formulation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
Australia, New South Wales | |
St Vincents Hospital | |
Sydney, New South Wales, Australia, 2010 |
Principal Investigator: | David A Cooper, MD | The National Centre in HIV Epidemiology and Clinical Research |
Study ID Numbers: | ASK-500 14047, ACTR012605000660684 |
Study First Received: | September 13, 2005 |
Last Updated: | June 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00192608 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Pharmacokinetic profile of atazanavir-saquinavir-ritonavir using saquinavir 500mg formulation. Treatment Experienced HIV |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Saquinavir Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Infection Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases |
Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |