Evaluation of Patients Who Have Not Had Success With Zidovudine
NCT ID: NCT00001025
Last Updated: 2021-11-01
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
120 participants
INTERVENTIONAL
1995-05-31
Brief Summary
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High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors.
Detailed Description
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One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated.
* Corticosteroids for no longer than 21 days (only as part of PCP therapy).
* Erythropoietin and G-CSF.
Patients must have:
* Documented HIV-seropositivity.
* CD4 count 100 - 300 cells/mm3.
* Prior continuous AZT dose = or \> 300 mg/day for 1 year or longer.
Prior Medication: Required:
* AZT for at least 1 year prior to study entry.
Exclusion Criteria
Patients with the following symptoms and conditions are excluded:
* Medical contraindication or is considered noncompliant in the opinion of the investigator.
* Peripheral neuropathy = or \> grade 2.
Concurrent Medication:
Excluded:
* Anti-HIV agents other than study drugs.
* Biologic response modifiers (other than erythropoietin or G-CSF).
* Systemic cytotoxic chemotherapy.
* Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression.
Concurrent Treatment:
Excluded:
* Radiation therapy.
Patients with the following prior conditions are excluded:
* History of acute or chronic pancreatitis, gout, or uric acid nephropathy.
Prior Medication:
Excluded:
* Other antiretrovirals besides AZT.
* ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry.
* Acute therapy for an infection or other medical illness within 14 days prior to study entry.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Corey L
Role: STUDY_CHAIR
Cavert W
Role: STUDY_CHAIR
Coombs R
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
San Francisco Gen Hosp
San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
SUNY / State Univ of New York
Syracuse, New York, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Cavert W, Coombs RW, Kuritzkes D, Grimes J, Stein D, Rojo W, Beatty C, Winters M, Corey L. Baseline zidovudine (ZDV) susceptibility, codon 215 mutation, viral load and syncytium-inducting characteristics(SI) of HIV isolates from ACTG protocol 194. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:137
Reichelderfer PS, Coombs RW. Multifactorial analysis of the inverse relationship between viral load and CD4+ cell count. Int Conf AIDS. 1996 Jul 7-12;11(2):277 (abstract no ThB4148)
Other Identifiers
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11170
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 194
Identifier Type: -
Identifier Source: org_study_id