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

October 28, 2005
April 26, 2011
March 2006
November 2007   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00246610 on ClinicalTrials.gov Archive Site
  • 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 ]
Pharmacokinetic evaluation of nelfinavir and M8 levels Maternal plasma HIV RNA, CD4/CD8 other Grade 3 or 4 adverse events Adherence
Not Provided
Not Provided
 
Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
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

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
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
Experimental: Open-label
Non-randomized, open-label, single-arm
Intervention: Drug: Nelfinavir mesylate, 625 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00246610
A4301017
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

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