Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000765 |
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.
Condition | Intervention |
---|---|
HIV Infections |
Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo) |
Estimated Enrollment: | 80 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria:
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Concurrent Medication:
Excluded:
United States, California | |
Palo Alto Veterans Administration Med Ctr | |
Palo Alto, California, United States, 94304 | |
Cedars Sinai Med Ctr | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
Broward Gen Med Ctr | |
Fort Lauderdale, Florida, United States, 33316 | |
United States, Illinois | |
Univ of Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Univ School of Medicine | |
Baltimore, Maryland, United States, 212872080 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, Rhode Island | |
Miriam Hosp / Brown Univ | |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
Houston Clinical Research Network | |
Houston, Texas, United States, 77006 |
Study Chair: | M Niu | |
Study Chair: | H Standiford |
Study ID Numbers: | DATRI 002 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000765 |
Health Authority: | United States: Federal Government |
Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |