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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000700 |
To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP |
Estimated Enrollment: | 482 |
Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with active opportunistic infections will be excluded.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Prior Treatment:
Excluded within 30 days of study entry:
Required:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Montefiore Med Ctr / Bronx Municipal Hosp | |
Bronx, New York, United States, 10467 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
Beth Israel Med Ctr / Peter Krueger Clinic | |
New York, New York, United States, 10003 | |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
Elmhurst, New York, United States, 11373 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Univ of Pittsburgh Med School | |
Pittsburgh, Pennsylvania, United States | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98105 |
Study Chair: | Fischl M |
Study ID Numbers: | ACTG 002 |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000700 |
Health Authority: | United States: Federal Government |
United States AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome Zidovudine |
Virus Diseases Opportunistic Infections Pneumonia, Pneumocystis Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Opportunistic Infections Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes Pneumonia |
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 |