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A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. 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 Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. Clinical research trials and A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. 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 Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.. A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. 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 Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. clinical trial. Human subjects often get the best healthcare possible for their A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC. 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 Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.  A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the long-term safety and effectiveness of the drug 2',3'-dideoxycytidine ( zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ). Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS.
Details: Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS. A range of doses of ddC is given to patients with AIDS and ARC. Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks. Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum (the fluid portion of the blood) are continued at that dose for an additional 12 weeks. Patients who do not respond at a given dose level (no rise in T4 or fall in serum HIV antigen) stop treatment at 12 weeks. All patients are followed off therapy for 4 weeks. As each dose level is found to be well tolerated for 10 weeks in five of the eight patients in each group, additional patients will be entered at higher dose levels until eight AIDS and eight ARC patients are receiving the drug at a given level.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents. - Acute therapy (7 days) with oral acyclovir. - Acute therapy with ketoconazole. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Negative antigen test within 2 weeks of starting therapy. - Significant malabsorption (> 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml). - Significant cardiac, liver, or neurologic disease. - For group A: - Opportunistic infection or malignancy fulfilling definition of AIDS, or with concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. - For group B: - Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the 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. Concurrent Medication: Excluded: - Acyclovir therapy. - Chemoprophylaxis for Pneumocystis carinii pneumonia. - Other antiretroviral agents, biologic modifiers, or systemic corticosteroids. - Other experimental medications, sedatives, and barbiturates. - Group B: - Therapy and/or prophylaxis for AIDS-defining opportunistic infection, antineoplastic therapy. Concurrent Treatment: Excluded: Transfusion dependency (requiring 2 units of blood more than once per month). Patients with history of idiopathic thrombocytopenia purpura are excluded. Prior Medication: Excluded within 30 days of study entry: - Biologic modifiers or corticosteroids. - Excluded within 90 days of study entry: - Antiretroviral agents. Prior Treatment: Excluded within 2 weeks of study entry: - Transfusion. Inclusion criteria are: - Consistently positive HIV antigen as defined by Abbott HIV antigen test. This demonstration will be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy. - HIV antigen titer must be = or > 100 pg. - Positive antibody to HIV confirmed by any federally licensed enzyme-linked immunosorbent assay (ELISA) test kit. The following conditions are allowed: Basal cell carcinoma of the skin or in situ carcinoma of the cervix. Active substance abuse.
Total Enrollment: 64
Location and Contact Information:
Overall Study Official:
MeriganTC, Study Chair,
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: ACTG 012;
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000704
Other Hiv Infections Studies:
1. Kidney and Liver Transplantation in People with HIV
2. Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs
3. A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
4. A Study of WF 10 IV Solution in Patients with Advanced HIV Disease
5. A Phase I Trial of Tecogalan sodium (DS-4152) Administered as an Infusion Every 21 Days
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A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
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