Status:
COMPLETED
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Glaxo Wellcome
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
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 vi...
Detailed Description
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 th...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00000765
End Date
June 1 2002
Last Update
October 28 2021
Active Locations (9)
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1
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
2
Palo Alto Veterans Administration Med Ctr
Palo Alto, California, United States, 94304
3
Broward Gen Med Ctr
Fort Lauderdale, Florida, United States, 33316
4
Univ of Illinois
Chicago, Illinois, United States, 60612