Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
2 other identifiers
interventional
80
1 country
9
Brief Summary
To evaluate the safety and efficacy of early treatment with zidovudine for preventing a decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the natural history of virologic and immunologic changes in primary HIV infection. Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
9 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Medications for nausea, vomiting, analgesia, or anxiety.
- Patients must have:
- Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria:
- p24 antigenemia documented within 1 month prior to study entry and either HIV enzyme immunoassay (IA) negative or HIV IA positive with Western blot negative/indeterminate, within 1 month prior to study entry.
- Documented seroconversion within 1 month prior to study entry and Western blot negative/indeterminate.
- Consent of parent or guardian if less than 18 years of age.
You may not qualify if:
- Co-existing Condition:
- Patients with the following condition are excluded:
- poor venous access.
- Concurrent Medication:
- Excluded:
- Chronic steroid use.
- Immunomodulators.
- Myelosuppressive agents.
- Other antiretroviral agents or experimental therapies (NOTE: FDA-approved therapies permitted in patients who qualify after week 24; experimental therapies permitted after study week 48).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
Palo Alto Veterans Administration Med Ctr
Palo Alto, California, 94304, United States
Broward Gen Med Ctr
Fort Lauderdale, Florida, 33316, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 212872080, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Related Publications (1)
Holodniy M, Niu M, Bethel J, Standiford H, Schnittman S. A pilot study to evaluate the efficacy of zidovudine (ZDV) versus placebo in primary HIV infection (DATRI 002): a preliminary analysis. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):26 (abstract no LBB6022)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M Niu
- STUDY CHAIR
H Standiford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
June 1, 2002
Last Updated
October 28, 2021
Record last verified: 2021-10