NCT00246610

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2006

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

October 28, 2005

Last Update Submit

April 26, 2011

Conditions

HIV Infection

Keywords

Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.

Outcome Measures

Primary Outcomes (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 Outcomes (7)

  • 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

  • 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

  • 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

  • Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts

    32 Weeks

  • 12-hour pharmacokinetic evaluation of nelfinavir

    32 Weeks

  • +2 more secondary outcomes

Study Arms (1)

Open-label

EXPERIMENTAL

Non-randomized, open-label, single-arm

Drug: Nelfinavir mesylate, 625 mg

Interventions

Nelfinavir mesylate, 625 mgDRUG

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.

Also known as: VIRACEPT plus Combivir
Open-label

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infection
  • Second trimester of pregnancy

You may not qualify if:

  • Major current or prior history of obstetrical complications
  • Serious current medical diseases
  • Evidence of HIV virus resistance to antiretroviral agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Jacksonville, Florida, 32209, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19410, United States

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Nelfinavirlamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

US(5)CA(1)