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

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Jacksonville, Florida, 32209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infection
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- HIV infection

- Second trimester of pregnancy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Major current or prior history of obstetrical complications

- Serious current medical diseases

- Evidence of HIV virus resistance to antiretroviral agents

NCT00246610
Pfizer
Completed
Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy

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Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
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
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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
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
Experimental: Open-label
Non-randomized, open-label, single-arm
Intervention: Drug: Nelfinavir mesylate, 625 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00246610
A4301017
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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