Full Text View
Tabular View
No Study Results Posted
Related Studies
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
This study has been completed.
First Received: November 2, 1999   Last Updated: August 19, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000831
  Purpose

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI.

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Didanosine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 280
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

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

Co-existing Condition:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000831

  Hide Study Locations
Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
George Washington Univ / Hershey Med Ctr
Washington, District of Columbia, United States, 20037
Georgetown Univ Hosp
Washington, District of Columbia, United States, 20037
United States, Georgia
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States, 303652225
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Iowa
Great Plains - Hemophilia / Univ of Iowa Hosp & Clinic
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, United States, 01605
United States, Michigan
Michigan State Univ Hemophilia Comprehensive Care Clinic
Lansing, Michigan, United States, 48912
United States, Minnesota
St Paul Ramsey Med Ctr
St Paul, Minnesota, United States, 55101
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, New Jersey
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, United States, 08903
United States, New York
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Mount Sinai Med Ctr
New York, New York, United States, 10029
Cornell Univ Med Ctr
New York, New York, United States, 10021
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10467
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, United States, 10029
United States, North Carolina
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Texas
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, United States, 77030
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
Investigators
Study Chair: Katzenstein D
Study Chair: Hammer S
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 302
Study First Received: November 2, 1999
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00000831     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
AIDS-Related Complex
Antiviral Agents
Zidovudine
Stavudine
Lamivudine
Drug Combinations

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 25, 2009