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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label

Non-randomized, open-label, single-arm

Group Type EXPERIMENTAL

Nelfinavir mesylate, 625 mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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VIRACEPT plus Combivir

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No