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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246610
• Other study ID #: A4301017
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2005
• Last updated: April 26, 2011
• Start date: March 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Nelfinavir mesylate, 625 mg
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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts		32 Weeks	No
Secondary	12-hour pharmacokinetic evaluation of nelfinavir		32 Weeks	No
Secondary	Maternal plasma HIV RNA		32 Weeks	No
Secondary	Immunologic response as measured by CD4 and CD8 cell count		32 Weeks	No

External Links

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