Clinical trial NCT00246610: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
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
timeFrame: 32 Weeks
Secondary outcomes:
measure: 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
timeFrame: 32 Weeks
measure: 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
timeFrame: 32 Weeks
measure: Adverse pregnancy events which cannot be directly attributed to another cause other than study treatment after consultation with Pfizer Clinician and Site Investigator
timeFrame: 32 Weeks
measure: Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts
timeFrame: 32 Weeks
measure: 12-hour pharmacokinetic evaluation of nelfinavir
timeFrame: 32 Weeks
measure: Maternal plasma HIV RNA
timeFrame: 32 Weeks
measure: Immunologic response as measured by CD4 and CD8 cell count
timeFrame: 32 Weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: