Back to resultsSafety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Nelfinavir mesylate, 625 mg
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label
Arm Description
Non-randomized, open-label, single-arm
Outcomes
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
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
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
Adverse pregnancy events which cannot be directly attributed to another cause other than study treatment after consultation with Pfizer Clinician and Site Investigator
Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts
12-hour pharmacokinetic evaluation of nelfinavir
Maternal plasma HIV RNA
Immunologic response as measured by CD4 and CD8 cell count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00246610
Brief Title
Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label
Arm Type
Experimental
Arm Description
Non-randomized, open-label, single-arm
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate, 625 mg
Other Intervention Name(s)
VIRACEPT plus Combivir
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts
Time Frame
32 Weeks
Title
12-hour pharmacokinetic evaluation of nelfinavir
Time Frame
32 Weeks
Title
Maternal plasma HIV RNA
Time Frame
32 Weeks
Title
Immunologic response as measured by CD4 and CD8 cell count
Time Frame
32 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19410
Country
United States
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4301017&StudyName=Safety%20Of%20VIRACEPT%3B%20625%20mg%20Administered%20To%20HIV-Infected%20Women%20During%20Pregnancy
Description
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Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
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