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

Study Overview
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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

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Nelfinavir mesylate, 625 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label<br>Non-randomized, open-label, single-arm | Drug: Nelfinavir mesylate, 625 mg<br>* 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.<br>* Other names: VIRACEPT plus Combivir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maternal plasma HIV RNA |  | 32 Weeks | 
| Immunologic response as measured by CD4 and CD8 cell count |  | 32 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.