Evaluation of Patients Who Have Not Had Success With Zidovudine
A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance
2 other identifiers
interventional
120
1 country
18
Brief Summary
To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate measures of viral load and short term clinical and laboratory markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the different therapy arms. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibbcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Glaxo Wellcomecollaborator
Study Sites (18)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Univ of Washington
Seattle, Washington, 981224304, United States
Related Publications (2)
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
BACKGROUNDReichelderfer 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Corey L
- STUDY CHAIR
Cavert W
- STUDY CHAIR
Coombs R
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 1995
Last Updated
November 1, 2021
Record last verified: 2021-10