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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00246610

First received: October 28, 2005

Last updated: April 26, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2005

Last Updated Date

April 26, 2011

Start Date ^ICMJE

March 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00246610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
12-hour pharmacokinetic evaluation of nelfinavir [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
Maternal plasma HIV RNA [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
Immunologic response as measured by CD4 and CD8 cell count [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetic evaluation of nelfinavir and M8 levels Maternal plasma HIV RNA, CD4/CD8 other Grade 3 or 4 adverse events Adherence

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

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.

Other Name: VIRACEPT plus Combivir

Study Arm (s)

Experimental: Open-label

Non-randomized, open-label, single-arm

Intervention: Drug: Nelfinavir mesylate, 625 mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00246610

Other Study ID Numbers ^ICMJE

A4301017

Has Data Monitoring Committee

Yes

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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