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

This study has been completed.

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Delavirdine Delavirdine mesylate Indinavir Indinavir Sulfate

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	228G, M/3331/0072
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002236 History of Changes
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:

Antimetabolites
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Indinavir
Acquired Immunodeficiency Syndrome
Zidovudine
Delavirdine
Antiviral Agents

Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Zidovudine
Delavirdine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009