Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
NCT ID: NCT00000765
Last Updated: 2021-10-28
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
NA
80 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
Detailed Description
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Patients are randomized to receive either zidovudine or placebo daily for 24 weeks. Patients are followed until development of an AIDS-related opportunistic infection or malignancy. After week 24, patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies. After study week 48, patients may co-enroll on another clinical trial to receive experimental therapy.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Medications for nausea, vomiting, analgesia, or anxiety.
Patients must have:
* Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria:
1. 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.
2. 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.
Exclusion Criteria
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).
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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M Niu
Role: STUDY_CHAIR
H Standiford
Role: STUDY_CHAIR
Locations
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Cedars Sinai Med Ctr
Los Angeles, California, United States
Palo Alto Veterans Administration Med Ctr
Palo Alto, California, United States
Broward Gen Med Ctr
Fort Lauderdale, Florida, United States
Univ of Illinois
Chicago, Illinois, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Countries
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References
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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)
Other Identifiers
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11733
Identifier Type: REGISTRY
Identifier Source: secondary_id
DATRI 002
Identifier Type: -
Identifier Source: org_study_id