A Study of Viracept in HIV-Positive Women

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Agouron Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002171

Purpose

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	Intervention	Phase
HIV Infections	Drug: Nelfinavir mesylate	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002171

Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of Southern California / LA County USC Med Cntr
Los Angeles, California, United States, 90033
United States, Louisiana
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, United States, 70112
United States, Texas
Baylor Univ
Houston, Texas, United States, 77009

Sponsors and Collaborators

Agouron Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002171 History of Changes
Other Study ID Numbers:	259D, Study 534, AG1343 - 534
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Placebos
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors

Lamivudine
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

HIV Protease Inhibitors
Nelfinavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012