The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-Infected Pregnant Women.
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| ClinicalTrials.gov Identifier: NCT00145561 |
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Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : October 22, 2008
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Sponsor:
Radboud University
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University
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Brief Summary:
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Saquinavir and Ritonavir | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| 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) |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | February 2008 |
Primary Outcome Measures :
- pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
Secondary Outcome Measures :
- antiviral activity
- safety
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| 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 |
| First Posted: | September 5, 2005 Key Record Dates |
| Last Update Posted: | October 22, 2008 |
| Last Verified: | October 2008 |
Keywords provided by Radboud University:
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HIV |
Additional relevant MeSH terms:
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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 |