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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00246610
Collaborator
(none)
16
Enrollment
6
Locations
1
Arm
20
Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Nelfinavir mesylate, 625 mg
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • VIRACEPT plus Combivir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts [32 Weeks]

    5. 12-hour pharmacokinetic evaluation of nelfinavir [32 Weeks]

    6. Maternal plasma HIV RNA [32 Weeks]

    7. Immunologic response as measured by CD4 and CD8 cell count [32 Weeks]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Jacksonville Florida United States 32209
    2 Pfizer Investigational Site Miami Florida United States 33136
    3 Pfizer Investigational Site Metairie Louisiana United States 70006
    4 Pfizer Investigational Site Detroit Michigan United States 48201
    5 Pfizer Investigational Site Philadelphia Pennsylvania United States 19410
    6 Pfizer Investigational Site Toronto Ontario Canada M5G 2N2

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00246610
    Other Study ID Numbers:
    • A4301017
    First Posted:
    Oct 30, 2005
    Last Update Posted:
    Apr 28, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    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

    Study Results

    No Results Posted as of Apr 28, 2011