Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Nelfinavir mesylate, 625 mg

• Registration Number: NCT00246610
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-10-30
• Study Start: 2006-03
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-26
• Last Update Posted: 2011-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• HIV infection
• Second trimester of pregnancy

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Exclusion Criteria

• Major current or prior history of obstetrical complications
• Serious current medical diseases
• Evidence of HIV virus resistance to antiretroviral agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label	Nelfinavir mesylate, 625 mg	Non-randomized, open-label, single-arm

Primary Outcome Measures

Name	Time	Method
Presence or absence of at least one adverse event related to or possibly related to nelfinavir of Grade 2 or greater severity as defined by the DAIDS Table for Grading of Severity of Adult Adverse Experiences in the gastrointestinal or hepatic category	32 Weeks

Secondary Outcome Measures

Name	Time	Method
Maternal plasma HIV RNA	32 Weeks
12-hour pharmacokinetic evaluation of nelfinavir	32 Weeks
Development of primary or active site protease and nucleoside reverse transcriptase inhibitor-associated resistance mutations assessed using standard HIV genotype test on maternal plasma samples	32 Weeks
Presence or absence of at least one adverse event of Grade 3 or 4 severity in the hematologic, cardiovascular or metabolic categories defined by DAIDS Table or in the dermatologic category as defined by the Supplemental Toxicity Table	32 Weeks
Adverse pregnancy events which cannot be directly attributed to another cause other than study treatment after consultation with Pfizer Clinician and Site Investigator	32 Weeks
Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts	32 Weeks
Immunologic response as measured by CD4 and CD8 cell count	32 Weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Toronto, Ontario, Canada