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The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC Clinical research trials and The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC. The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC clinical trial. Subjects often receive the most expert healthcare possible for their The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC  The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC
The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity. Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
Details: Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT. This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (> 72 hours) administration is not advised without dose supervision. Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories: - AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol. - Patients who qualify for AZT under the labeling: - (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and < 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or > 15 lbs or > 10 percent of total body weight within the previous 3 months) and < 200 T4 cells and one or more of the following symptoms: - (1) fever > 100 degrees F without infectious cause of > 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare. Note: - Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling. Exclusion Criteria Co-existing Condition: - Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded. Concurrent Medication: Excluded: - Acetaminophen.
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
PettinelliC, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
LaJolla Veterans Administration Med Ctr
LaJolla, California, 92037
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
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
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: ACTG 020;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000999
Other Hiv Infections Studies:
1. Consent for Use of Stored Patient Specimens for Future Testing
2. HIV Incidence and Participation Retention in Pune, India
3. Identifying Emergency Room Patients Who Have Recently Been Infected with HIV
4. The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
5. A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC
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