Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
Pfizer
ClinicalTrials.gov Identifier
NCT00246610

First received: October 28, 2005
Last updated: April 26, 2011
Last Verified: April 2011
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infection

Drug : Nelfinavir mesylate, 625 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Pfizer:

Primary Outcome Measures

  • 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 Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: March 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Open-label
Non-randomized, open-label, single-arm
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
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246610

Locations

United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Louisiana
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19410
Canada
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer
More Information

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc.  
ClinicalTrials.gov Identifier: NCT00246610   History of Changes  
Other Study ID Numbers: A4301017  
Study First Received: October 28, 2005  
Last Updated: April 26, 2011  

Keywords provided by Pfizer:

Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.

Additional relevant MeSH terms:
HIV Infections
Nelfinavir
Lamivudine, zidovudine drug combination

ClinicalTrials.gov processed this data on September 17, 2019
This information is provided by ClinicalTrials.gov.