Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
- Conditions
- HIV Infections
- Registration Number
- NCT00000765
- 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.
- 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 the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (9)
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Houston Clinical Research Network
🇺🇸Houston, Texas, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Palo Alto Veterans Administration Med Ctr
🇺🇸Palo Alto, California, United States
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Broward Gen Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Johns Hopkins Univ School of Medicine
🇺🇸Baltimore, Maryland, United States
Cedars Sinai Med Ctr
🇺🇸Los Angeles, California, United States