- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000939
A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
Phase II Randomized, Open-Label Study of Maintenance of HIV RNA Suppression After Switching to ddI/d4T/HU vs. ddI/d4T/EFV vs. Continuing the Pre-Entry Protease Inhibitor Regimen
This study will look at different anti-HIV drug regimens to see which works best to keep the level of HIV (viral load) in the blood as low as possible during maintenance therapy. You will be assigned randomly (like tossing a coin) to 1 of 3 groups:
Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their current drug regimens. This study will last approximately 3 years; you will receive study medications for the duration of the study.
Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral load. However, some patients have a rise in HIV levels while on PI maintenance. It may be possible to keep HIV levels low using another class of drugs for maintenance that are easier to take and less expensive than PIs. If viral load increases while a patient is taking this second group of drugs, it may be possible to restart the PI drug regimen and again decrease HIV levels.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Combination antiretroviral therapies using protease inhibitors (PIs) are capable of suppressing plasma HIV RNA to undetectable levels. However, approximately 10% of patients who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year. When HIV replication has been suppressed to very low levels, it may be possible to consolidate antiretroviral therapy into a simpler and potentially less toxic "maintenance" regimen without a PI. Such a regimen would ideally be potent enough to continue to maintain viral suppression but use agents that are better tolerated, more easily salvaged, less expensive, and/or more convenient than PI-containing regimens. Subsequent rises in HIV viremia with non-PI maintenance regimens may respond to resumption of the pre-maintenance PI-containing regimen, extending the use of the potent PI class.
Patients are randomized 1:1:1 to treatment with ddI/d4T/HU (Arm A) versus ddI/d4T/EFV (Arm B) versus continuation of the pre-entry PI-containing regimen (Arm C). Viral load is measured at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, then every 8 weeks for up to 3 years. Upon virologic failure (plasma HIV RNA greater than or equal to 200 copies/ml), or drug intolerance, patients on the maintenance regimens (Arms A and B) restart their pre-entry PI-containing regimen. Patients on Arm C are managed according to best medical judgment of their primary care provider in the event of virologic failure.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Menlo Park, California, United States, 94025
- Willow Clinic
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San Jose, California, United States, 951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
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Stanford, California, United States, 943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford, California, United States, 943055107
- Stanford Univ Med Ctr
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
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New York
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10021
- Chelsea Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
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Columbus, Ohio, United States, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania at Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
You may be eligible for this study if you:
- Are at least 13 years old (need consent if under 18).
- Are HIV-positive.
- Are taking your first anti-HIV drug regimen, which must include a PI and at least one NRTI (nucleoside reverse transcriptase inhibitor) and have been on this regimen for at least 12 months.
- Have a viral load less than 400 copies/ml for at least 12 months prior to study entry, and have a viral load less than 50 copies/ml within 60 days of study entry.
- Have a CD4 cell count of at least 200 cells/mm3 within 60 days of study entry.
- Are willing to go back on the drugs you are currently on, if necessary.
- Are willing to use effective methods of birth control during the study and for 3 months after.
Exclusion Criteria
You will not be eligible for this study if you:
- Have taken ddI, d4T, or HU for more than 2 weeks.
- Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7 days.
- Have ever taken EFV.
- Have received an HIV vaccine within 30 days prior to study entry.
- Have an AIDS-related cancer that requires chemotherapy.
- Have or have had pancreatic disease.
- Are being treated for a significant illness.
- Abuse drugs or alcohol.
- Are pregnant or breast-feeding.
- Are allergic to any study drugs.
- Have received certain medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: David Wohl
- Study Chair: Joe Eron
- Study Chair: Roy Gulick
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
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
- Antineoplastic Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Antisickling Agents
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Stavudine
- Hydroxyurea
- Didanosine
- Efavirenz
Other Study ID Numbers
- A5039
- 10885 (Registry Identifier: DAIDS ES)
- ACTG A5039
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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