A Study of Viracept in HIV-Positive Women

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002171

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nelfinavir mesylate	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Viracept in Combination With Antiretroviral Therapy in HIV Positive Women With <= 1 Month of Prior Treatment With d4T and/or 3TC

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Univ of Southern California / LA County USC Med Cntr	Los Angeles	California	United States	90033
3	HIV Outpatient Clinics / LA State Univ Med Ctr	New Orleans	Louisiana	United States	70112
4	Baylor Univ	Houston	Texas	United States	77009