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

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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS and Pregnancy

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]


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


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

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, 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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


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
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016