A Phase IV, Non-Randomized, Open-Label Trial Evaluating The Safety Of 625 mg Formulation Of VIRACEPT When Administered To HIV-Infected Women During Pregnancy

Pfizer1 site in 1 country16 target enrollmentMarch 2006

ConditionsHIV Infection

InterventionsNelfinavir mesylate, 625 mg

DrugsNelfinavir mesylate, 625 mg

Overview

Phase: Phase 4
Intervention: Nelfinavir mesylate, 625 mg
Conditions: HIV Infection
Sponsor: Pfizer
Enrollment: 16
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

November 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•HIV infection
•Second trimester of pregnancy

Exclusion Criteria

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

Arms & Interventions

Open-label

Non-randomized, open-label, single-arm

Intervention: Nelfinavir mesylate, 625 mg

Outcomes

Primary Outcomes

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

Time Frame: 32 Weeks

Secondary Outcomes

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)
12-hour pharmacokinetic evaluation of nelfinavir(32 Weeks)
Maternal plasma HIV RNA(32 Weeks)
Immunologic response as measured by CD4 and CD8 cell count(32 Weeks)