Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
NCT ID: NCT00000831
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
1998-05-31
Brief Summary
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Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
Detailed Description
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Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period.
AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Lamivudine
Stavudine
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Recommended:
* PCP prophylaxis in patients with CD4 count \<= 200 cells/mm3.
Allowed:
* Chemophylaxis against Mycobacterium tuberculosis.
* Acyclovir.
* Vaccination with pneumococcal vaccine polyvalent.
* Haemophilus B Conjugate vaccine.
* Chemoprophylaxis for MAC and Toxoplasma gondii.
* Antibiotics.
* Recombinant erythropoietin ( EPO ) and G-CSF.
* Systemic corticosteroids for \< 21 days.
* Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives.
* Vitamins and herbal therapies.
Concurrent Treatment:
Allowed:
* Limited local radiation therapy to skin.
* Blood transfusions if 3 units or less per 21-day period.
* Acupuncture.
* Visualization techniques.
Patients must have:
* Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval.
* Not reached an ACTG 175 endpoint prior to May 1, 1995.
* Consent of parent or guardian if less than 18 years old.
PER AMENDMENT 8/27/96:
* Patients must be on study/on treatment at the time the protocol study treatment is extended.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Grade 2 or worse peripheral neuropathy.
* Malignancy requiring systemic therapy.
Concurrent Medication:
Excluded:
* Anti-HIV drugs other than study drugs.
* Biologic response modifiers.
* Systemic cytotoxic chemotherapy.
* Any drug known to affect glucuronidation and/or clearance of AZT.
Concurrent Treatment:
Excluded:
* Radiation therapy other than limited local therapy to skin.
Patients with the following prior condition are excluded:
* History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
* Prior 3TC.
* Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry.
Current ethanol abuse.
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Katzenstein D
Role: STUDY_CHAIR
Hammer S
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Emory Univ. Hemophilia Program Office
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Cornell University A2201
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, , Tanzania
Countries
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References
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Shulman NS, Machekano RA, Shafer RW, Winters MA, Zolopa AR, Liou SH, Hughes M, Katzenstein DA; AIDS Clinical Trials Group 302 Study Team. Genotypic correlates of a virologic response to stavudine after zidovudine monotherapy. J Acquir Immune Defic Syndr. 2001 Aug 1;27(4):377-80. doi: 10.1097/00126334-200108010-00008.
Katzenstein DA, Hughes M, Albrecht M, Hammer S, Para M, Murphy R, Valdez H, Haubrich R, Liou S. Virologic and CD4+ cell responses to new nucleoside regimens: switching to stavudine or adding lamivudine after prolonged zidovudine treatment of human immunodeficiency virus infection. ACTG 302 Study Team. AIDS Clinical Trials Group. AIDS Res Hum Retroviruses. 2000 Jul 20;16(11):1031-7. doi: 10.1089/08892220050075282.
Shulman NS, Hughes MD, Winters MA, Shafer RW, Zolopa AR, Hellmann NS, Bates M, Whitcomb JM, Katzenstein DA. Subtle decreases in stavudine phenotypic susceptibility predict poor virologic response to stavudine monotherapy in zidovudine-experienced patients. J Acquir Immune Defic Syndr. 2002 Oct 1;31(2):121-7. doi: 10.1097/00126334-200210010-00001.
Other Identifiers
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11277
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 302
Identifier Type: -
Identifier Source: org_study_id