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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00246610
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:

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
HIV Infection Drug: Nelfinavir mesylate, 625 mg Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 Name: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 32 Weeks ]
  4. Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts [ Time Frame: 32 Weeks ]
  5. 12-hour pharmacokinetic evaluation of nelfinavir [ Time Frame: 32 Weeks ]
  6. Maternal plasma HIV RNA [ Time Frame: 32 Weeks ]
  7. Immunologic response as measured by CD4 and CD8 cell count [ Time Frame: 32 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00246610     History of Changes
Other Study ID Numbers: A4301017
First Posted: October 31, 2005    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nelfinavir
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors