- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002199
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med Ctr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
GM-CSF, G-CSF, and erythropoietin.
Concurrent Treatment:
Allowed:
Local treatment for Kaposi's sarcoma.
Patients must have:
- HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
- CD4+ cell count >= 100 cells/mm3 within 14 days prior to study drug administration.
- HIV-1 RNA >= 10,000 copies/ml within 14 days prior to study drug administration.
- No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts < 200 cells/mm3).
- Signed, informed consent from parent or legal guardian for patients under 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient.
Concurrent Medication:
Excluded:
- Cytotoxic chemotherapeutic agents.
- Agents with documented anti-HIV-1 activity in vitro.
- Foscarnet.
- Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, or interferons.
- Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine.
Concurrent Treatment:
Excluded:
- Radiation therapy.
- Other investigational treatments. NOTE:
- Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually.
Patients with the following prior conditions are excluded:
History of relevant pancreatitis or hepatitis in the last 6 months.
Prior Medication:
Excluded:
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
- Prior antiretroviral therapy.
- HIV vaccine dose within 90 days of study drug administration.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry.
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration.
Current alcohol or illicit drug use that may interfere with patient compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
Collaborators and Investigators
Sponsor
Publications and helpful links
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
- Indinavir
- Abacavir
- Lamivudine, zidovudine drug combination
Other Study ID Numbers
- 238K
- CNAA/B3005
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 WellcomeCompletedHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompleted