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

Pfizer16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection

Interventions

Nelfinavir mesylate, 625 mgDRUG

Nelfinavir 625 mg \[dosed orally as 1250 mg BID (two 625 mg tablets given orally BID)\] plus Combivir (lamivudine 150 mg plus zidovudine 300 mg BID dosed orally) administered with food. Subjects will start treatment at their baseline visit. Subjects will be treated for up to 26 weeks during pregnancy plus 6 weeks postpartum.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

Metairie, Louisiana, United States

Pfizer Investigational Site

Detroit, Michigan, United States

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

Time frame: 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

Time frame: 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

Time frame: 32 Weeks

Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts

Time frame: 32 Weeks

12-hour pharmacokinetic evaluation of nelfinavir

Time frame: 32 Weeks

Maternal plasma HIV RNA

Time frame: 32 Weeks

Immunologic response as measured by CD4 and CD8 cell count

Time frame: 32 Weeks

Data from ClinicalTrials.gov

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