|
A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) Clinical research trials and A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC). A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)  A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC). Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Details: Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC. Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC. Patients are evaluated every week for the first 10 weeks and biweekly thereafter.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine 300 mg per 4 weeks. - Drugs unlikely to cause increased toxicity with either study drug and unlikely to cause peripheral neuropathy. - Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity, that patient has been taking and tolerating well for ongoing condition. - Acyclovir (= or < 600 mg/day, orally). - Ketoconazole (= or < 400 mg/day). - Nystatin (occasional). - Acetaminophen or nonsteroidal antiinflammatory agents (low dose). - Drugs that could possibly cause serious additive toxicity when coadministered with either study drug, but unlikely to cause peripheral are allowed only if their use is anticipated for treatment of acute intercurrent illness or opportunistic infections. - Allowed only with a study drug interruption of up to 21 days per episode, for a total of 42 days for the study: - Acyclovir (> 600 mg/day). - Experimental drugs including ganciclovir. - Fluconazole. - Systemic pentamidine. - Pyrimethamine. - Triple sulfa. - Ansamycin. - Prolonged continuous use of high-dose nonsteroidal antiinflammatory agents. - Acetaminophen. - Amphotericin. - Foscarnet. Concurrent Treatment: Allowed: - Radiation therapy if unlikely to cause peripheral neuropathy if their use is anticipated for treatment of acute intercurrent illness or opportunistic infection. - Transfusion for anemia. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Active opportunistic infections requiring treatment with unallowed drugs. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within month prior to study entry, or with concurrent neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. - History of peripheral neuropathy or any significant signs or symptoms of neurological disease, or abnormality indicative of peripheral neuropathy. - Significant cardiac disease defined as history of ventricular arrhythmias requiring medication, prior myocardial infarction, or history of angina or ischemic changes on electrocardiogram. - Significant liver disease as defined by transaminase levels or by history of cirrhosis or ascites. - Significant renal disease defined by serum creatinine. Concurrent Medication: Excluded: - Experimental drugs including fluconazole, and foscarnet. - Immunomodulators including interferon, interleukins, or systemic corticosteroids. - Ganciclovir. - Neurotoxic drugs. - Drugs that could potentially cause peripheral neuropathy, including chloramphenicol, cisplatin, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, vincristine, and nitrofurantoin. - Excluded within 4 weeks of study entry: - Drugs that have caused significant nephrotoxicity or significant hepatotoxicity (as defined by transaminases). Concurrent Treatment: Excluded: - Transfusion dependent. Patients are excluded if unwilling or unable to sign informed consent. Prior Medication: Excluded: - Zidovudine (AZT). - Dideoxycytidine (ddC). - Any other nucleoside antiretrovirals. Positive antibody to HIV using any federally licensed ELISA test kit. Diagnosis of AIDS or AIDS-related complex (ARC). Active substance or alcohol abuse.
Total Enrollment: 68
Location and Contact Information:
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Additional Information:
Study ID Numbers: ACTG 106; Protocol N3447
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000978
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined with MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
2. The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS
3. A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
4. An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium avium-intracellulare Complex Infection (MAC) in Patients with Acquired Immune Deficiency Syndrome (AIDS)
5. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
|
|
|
|
|
|
|
|
