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The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-Infected Pregnant Women.
This study has been completed.
Sponsor:
Radboud University
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00145561
First received: September 2, 2005
Last updated: October 21, 2008
Last verified: October 2008
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Purpose
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Saquinavir and Ritonavir | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-Infected Pregnant Women (SARA) |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary Outcome Measures:
- antiviral activity
- safety
| 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 (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV infected woman
- 18 - 40 years of age
- able and willing to sign Informed Consent
- pregnant for a maximum of 31 weeks
Exclusion Criteria:
- history of sensitivity/idiosyncrasy to the drug
- relevant history of interference with drug metabolism
- inability to understand trial procedures
- abnormal specific serum levels
- use of specific concomitant medications
- active hepatobiliary or hepatic disease
- previous failure of saquinavir/ritonavir regimen
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00145561
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145561
Locations
| Germany | |
| University of Bonn | |
| Bonn, Germany, 53127 | |
| University of Cologne | |
| Köln, Germany | |
| Netherlands | |
| Rijnstate Hospital | |
| Arnhem, Netherlands, 6815AD | |
| University of Leiden | |
| Leiden, Netherlands, 2300RC | |
| Radboud University Medical Centre Nijmegen | |
| Nijmegen, Netherlands, 6500HB | |
| Erasmus Medical Centre | |
| Rotterdam, Netherlands | |
| 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 | |
Sponsors and Collaborators
Radboud University
Hoffmann-La Roche
Investigators
| Principal Investigator: | David M Burger, Dr | Radboud University |
More Information
| Responsible Party: | D.M. Burger PharmD PhD, hospital pharmacist, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00145561 History of Changes |
| Other Study ID Numbers: |
UMCN-AKF 04.02 MV19059 |
| Study First Received: | September 2, 2005 |
| Last Updated: | October 21, 2008 |
Keywords provided by Radboud University:
|
HIV |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Saquinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on August 21, 2017