- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002236
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
June 23, 2005 updated by: Pharmacia and Upjohn
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- AIDS Healthcare Foundation
-
San Francisco, California, United States, 94105
- UCSF AIDS Research Institute
-
-
New York
-
New York, New York, United States, 10019
- Saint Luke's - Roosevelt Hosp Ctr
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Anderson Clinical Research
-
-
Tennessee
-
Memphis, Tennessee, United States, 38165
- Univ of Tennessee / Div of Infect Dis / Dept of Med
-
-
Virginia
-
Annandale, Virginia, United States, 22203
- Infectious Disease Physicians Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Zidovudine
- Indinavir
- Delavirdine
Other Study ID Numbers
- 228G
- M/3331/0072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Indinavir sulfate
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...Withdrawn
-
Merck Sharp & Dohme LLCCompletedHIV InfectionsUnited States
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompletedHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Glaxo WellcomeCompleted