- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002168
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).
Patients will be treated for 48 weeks.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ponce, Puerto Rico, 00731
- Hosp Regional de Ponce - Area Vieja
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California
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Berkeley, California, United States, 94705
- East Bay AIDS Clinic
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Torrance, California, United States, 90509
- Harbor UCLA Med Ctr / Division of Immunology / N-24
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District of Columbia
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Washington, District of Columbia, United States, 20037
- Anderson Clinical Research
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Washington, District of Columbia, United States, 20037
- George Washington Med Ctr / Clinical Trials Unit
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Illinois
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Chicago, Illinois, United States, 60610
- Chicago Ctr for Clinical Research
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Chicago, Illinois, United States, 60611
- Northwestern Univ
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Nebraska
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Omaha, Nebraska, United States, 68195
- Univ of Nebraska
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Univ of North Carolina / Infectious Disease Division
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Charlotte, North Carolina, United States, 28207
- The Nalle Clinic / Clinical Research Dept
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania / Infectious Diseases Division
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Texas
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Dallas, Texas, United States, 75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Dallas, Texas, United States, 75225
- Southwest Infectious Disease Association / PA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
AIDS defining condition within 1 month of study entry.
Prior Medication:
Excluded:
Patients with any history of antiretroviral therapy treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Lamivudine
- Zidovudine
- Stavudine
- Indinavir
- Didanosine
Other Study ID Numbers
- 260B
- BMS 002
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.
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