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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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare possible for their 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 condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - All concomitant medication to minimum and record. - Any approved medications can be used to treat an opportunistic infection. - Dapsone may be used for Pneumocystis carinii pneumonia (PCP). - Pyrimethamine - sulfadoxine may be used for toxoplasmosis. - Ganciclovir for cytomegalovirus may be used for maintenance only. - Prophylactic therapy for PCP. Concurrent Treatment: Allowed: - Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used. Patients must have: - HIV seropositivity as confirmed by any federally licensed ELISA test kit. - Allowed: - Malignancy in past which has been in complete remission for 1 year without therapy. Exclusion Criteria Co-existing Condition: Patients with active opportunistic infections will be excluded. Concurrent Medication: Excluded: - Aspirin on a regular basis or beyond 72 hours without contacting investigator. - Cimetidine. - Flurazepam. - Indomethacin. - Ranitidine. - Probenecid. Patients with the following are excluded: - Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry. - Other concurrent neoplasms other than basal cell carcinoma of the skin. - Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry. - Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary. Prior Medication: Excluded within 2 weeks of study entry: - Treatment for acute Pneumocystis carinii pneumonia (PCP). - Excluded within 30 days of study entry: - Other antiretroviral agents, immunomodulating agents, or corticosteroids. Prior Treatment: Excluded within 30 days of study entry: - Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma. Required: - Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).
Total Enrollment: 482
Location and Contact Information:
Overall Study Official:
FischlM, Study Chair,
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Washington
Seattle, Washington, 98105
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: ACTG 002;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000700
Other Hiv Infections Studies:
1. Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.
2. A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
3. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection
4. A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
5. A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients with AIDS or AIDS-Related Complex
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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
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