A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
2 other identifiers
interventional
85
1 country
22
Brief Summary
To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV-1 seropositivity.
- CD4 count \>= 550 cells/mm3.
- Asymptomatic disease.
- No prior antiretroviral therapy.
- Consent of parent or guardian if less than 18 years old.
- PER AMENDMENT 6/18/96:
- Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Medical condition that precludes study compliance.
- Concurrent Medication:
- Excluded:
- Antiretrovirals other than study drugs.
- Biologic response modifiers including erythropoietin and G-CSF.
- Systemic corticosteroids.
- Systemic cytotoxic chemotherapy.
- Intravenous pentamidine.
- Concurrent Treatment:
- Excluded:
- Systemic radiation therapy.
- Patients with the following prior conditions are excluded:
- History of grade 2 or worse peripheral neuropathy.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Bristol-Myers Squibbcollaborator
- Glaxo Wellcomecollaborator
Study Sites (22)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, 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
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640, United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Washington
Seattle, Washington, 981224304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Collier AC
- STUDY CHAIR
Johnson V
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
February 1, 2000
Last Updated
October 28, 2021
Record last verified: 2021-10