A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients - Full Text View

A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

This study has been completed.

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002236

Purpose

The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Condition	Intervention
HIV Infections	Drug: Indinavir sulfate Drug: Delavirdine mesylate Drug: Zidovudine

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Indinavir Indinavir Sulfate Delavirdine mesylate Delavirdine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study

Official Title:	An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals

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

Estimated Enrollment:

Detailed Description:

Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
Have a CD4 cell count of at least 50 cells/mm3.
Are at least 14 years old (consent of parent or guardian is required if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

Have ever taken an anti-HIV drug other than ZDV.
Have taken ZDV for more than 1 month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002236

Locations


United States, California
	AIDS Healthcare Foundation
	Los Angeles, California, United States, 90027
	UCSF AIDS Research Institute
	San Francisco, California, United States, 94105

United States, New York
	Saint Luke's - Roosevelt Hosp Ctr
	New York, New York, United States, 10019

United States, Pennsylvania
	Anderson Clinical Research
	Pittsburgh, Pennsylvania, United States, 15213

United States, Tennessee
	Univ of Tennessee / Div of Infect Dis / Dept of Med
	Memphis, Tennessee, United States, 38165

United States, Virginia
	Infectious Disease Physicians Inc
	Annandale, Virginia, United States, 22203

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

Study ID Numbers:	228G, M/3331/0072
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002236
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Zidovudine

Drug Administration Schedule

HIV Protease Inhibitors

CD4 Lymphocyte Count

Indinavir

Delavirdine

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Viral Load

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Indinavir

HIV Seropositivity

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

Delavirdine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008