- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002225
A Study of Efavirenz in Combination With Stavudine and Didanosine
A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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District of Columbia
-
Washington, District of Columbia, United States, 20009
- The Whitman Walker Clinic
-
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Illinois
-
Chicago, Illinois, United States, 60657
- AIDS Research Alliance - Chicago
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New York
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Manhassett, New York, United States, 11030
- North Shore AIDS Hosp / Division of Infectious Disease
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Rochester, New York, United States, 14642
- Univ of Rochester Med Ctr
-
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Carolinas Research Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
- A life expectancy of at least 12 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Current bilateral peripheral neuropathy greater than or equal to Grade 2.
- Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
- Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination.
- Any malignancy that requires systemic therapy.
- Proven or suspected acute hepatitis due to any cause.
- Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing.
- Active AIDS-defining opportunistic infection or disease.
Concurrent Medication:
Excluded:
Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Life expectancy less than 12 months.
- Difficulty in swallowing capsules/tablets.
- Hypersensitivity to any component of the formulation of efavirenz, stavudine, or didanosine.
Prior Medication:
Excluded:
- Any other experimental drug within 30 days of introducing study treatment.
- Vaccination within 3 weeks of screening visit.
- Interferon started within 30 days of initiating study treatment.
- Prior antiretroviral therapy.
Risk Behavior:
Excluded:
- Current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
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
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
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Stavudine
- Didanosine
- Efavirenz
Other Study ID Numbers
- 281D
- DMP 266-044
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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