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Clinical Trial: Safety of VIRACEPT® 625 Mg During Pregnancy
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
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Purpose
This study is an evaluation of the safety of 625 mg formulation when administered to HIV-infected pregnant women from their second trimester through six weeks postpartum. The study will also evaluate the pharmacokinetics of VIRACEPT
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Pregnancy | Drug: nelfinavir mesylate, 625 mg Drug: zidovudine/lamivudine | Phase IV |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase 4, Non-Randomized, Open-Label Trial Evaluating the Safety of 625 Mg Formulation of VIRACEPT When Administered to HIV-Infected Women During Pregnancy
Further study details as provided by Pfizer:
Primary Outcomes: Presence or absence of at least one adverse event related to or possibly related to nelfinavir of Grade 2 or greater severity in the gastrointestinal or hepatic category
Secondary Outcomes: Pharmacokinetic evaluation of nelfinavir and M8 levels Maternal plasma HIV RNA, CD4/CD8 other Grade 3 or 4 adverse events Adherence
Expected Total Enrollment: 60
Secondary Outcomes: Pharmacokinetic evaluation of nelfinavir and M8 levels Maternal plasma HIV RNA, CD4/CD8 other Grade 3 or 4 adverse events Adherence
Expected Total Enrollment: 60
Study start: December 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- HIV infection
- second trimester of pregnancy
Exclusion Criteria:
- Major medical or obstetrical complications
- substance abuse
- presence of protease inhibitor mutations or NAM
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00246610
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A4301017
Last Updated: December 8, 2005
Record first received: October 28, 2005
ClinicalTrials.gov Identifier: NCT00246610
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 28, 2005
ClinicalTrials.gov Identifier: NCT00246610
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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