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| Sponsors and Collaborators: |
Radboud University Hoffmann-La Roche |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00145561 |
Purpose
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir and Ritonavir |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-Infected Pregnant Women (SARA) |
| Enrollment: | 40 |
| Study Start Date: | August 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| University of Cologne | |
| Köln, Germany | |
| University of Bonn | |
| Bonn, Germany, 53127 | |
| Netherlands | |
| Radboud University Medical Centre Nijmegen | |
| Nijmegen, Netherlands, 6500HB | |
| University of Leiden | |
| Leiden, Netherlands, 2300RC | |
| Erasmus Medical Centre | |
| Rotterdam, Netherlands | |
| Rijnstate Hospital | |
| Arnhem, Netherlands, 6815AD | |
| Spain | |
| University Hospital ''Germans Trias i Pujol'' | |
| Barcelona, Spain, 08916 | |
| Thailand | |
| Clinic Rajdumri Road Pathumwan | |
| Bangkok, Thailand, 10330 | |
| United Kingdom | |
| Birmingham Heartlands & Sollihull Hospital | |
| Birmingham, United Kingdom | |
| Chelsea and Westminster Hospital | |
| London, United Kingdom, SW10 9NH | |
| Principal Investigator: | David M Burger, Dr | Radboud University |
More Information
| Responsible Party: | Radboud University Nijmegen Medical Centre ( D.M. Burger PharmD PhD, hospital pharmacist ) |
| Study ID Numbers: | UMCN-AKF 04.02, MV19059 |
| Study First Received: | September 2, 2005 |
| Last Updated: | October 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00145561 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
HIV |
|
Virus Diseases Sexually Transmitted Diseases, Viral Saquinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |
