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A Study of Viracept in HIV-Positive Women

NCT ID: NCT00002171

Last Updated: 2005-06-24

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

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count \<= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 T cell count \<= 400 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
* Prior protease inhibitor therapy.
Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agouron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Univ of Southern California / LA County USC Med Cntr

Los Angeles, California, United States

Site Status

HIV Outpatient Clinics / LA State Univ Med Ctr

New Orleans, Louisiana, United States

Site Status

Baylor Univ

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Study 534

Identifier Type: -

Identifier Source: secondary_id

AG1343 - 534

Identifier Type: -

Identifier Source: secondary_id

259D

Identifier Type: -

Identifier Source: org_study_id