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Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
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Purpose
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: | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | June 2002 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00000765
| United States, California | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| Palo Alto Veterans Administration Med Ctr | |
| Palo Alto, California, United States, 94304 | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000765 History of Changes |
| Other Study ID Numbers: |
DATRI 002 11733 ( Registry Identifier: DAIDS ES Registry Number ) |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 15, 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Zidovudine |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Zidovudine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on July 21, 2017