The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
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ClinicalTrials.gov Identifier: NCT00145561 |
Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Saquinavir and Ritonavir | Phase 1 Phase 2 |
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 |

- pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
- antiviral activity
- safety

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | David M Burger, Dr | Radboud University Medical Center |
Publications of Results:
Responsible Party: | D.M. Burger PharmD PhD, hospital pharmacist, Radboud University Nijmegen Medical Centre |
ClinicalTrials.gov Identifier: | NCT00145561 |
Other Study ID Numbers: |
UMCN-AKF 04.02 MV19059 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | October 19, 2020 |
Last Verified: | October 2008 |
HIV |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir |
Saquinavir HIV Protease Inhibitors Viral 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 |