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A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT Clinical research trials and A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT. A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT  A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT
A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT
For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24 antigen, and clinical or immunologic parameters associated with AIDS. Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission. Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal studies of d4T show that the drug can inhibit replication (reproduction) of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity. These studies also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be possible for the drug to be as effective as AZT when taken less frequently than AZT. It also may have a less disturbing effect on other body functions (such as thymidine metabolism).
Details: Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission. Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal studies of d4T show that the drug can inhibit replication (reproduction) of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity. These studies also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be possible for the drug to be as effective as AZT when taken less frequently than AZT. It also may have a less disturbing effect on other body functions (such as thymidine metabolism). Five patients are enrolled at each dose level and receive d4T for 10 weeks at their initial dose level. Escalation to the next higher dose level, using a different group of five patients, occurs after three patients in the preceding group have successfully completed at least 3 weeks of oral dosing.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Diagnosis of AIDS or AIDS related complex (ARC). - Previous intolerance to daily doses of up to 1200 mg of zidovudine (AZT) demonstrated by a decrease in hemoglobin levels of 2 - 8.5 g/dl or AZT-related depression of neutrophils of 200 - 750 cells/mm3. - Ability to provide informed consent. Prior Medication: Allowed: - Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - AIDS-defining opportunistic infection on enrollment. - Intractable diarrhea. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - Any other clinical conditions or prior therapy which in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded: - Systemic maintenance or chemoprophylaxis for opportunistic infection (includes dapsone, acyclovir). - Systemic therapy with this or any other antiretroviral drug (except zidovudine (AZT)) or investigational drug. - Ribavirin. - Cytotoxic anticancer therapy. - Any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes (includes rifampin and barbiturates). - Trimethoprim / sulfamethoxazole (TMP / SMX). Patients with the following are excluded: - AIDS-defining opportunistic infection on enrollment. - Intractable diarrhea. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - Any other clinical conditions or prior therapy which in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements. Prior Medication: Excluded within 2 weeks of study entry: - Any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes (includes rifampin and barbiturates). Excluded within 1 month of study entry: - Systemic therapy with this or any other antiretroviral drug (except zidovudine (AZT)) or investigational drug. Excluded within 3 months of study entry: - Ribavirin. - Cytotoxic anticancer therapy. Active alcohol or drug abuse sufficient in investigator's opinion to prevent adequate compliance with study therapy.
Total Enrollment: 35
Location and Contact Information:
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: ACTG 111; AI455-004
Study Start Date:
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000686
Other Hiv Infections Studies:
1. A Study of L-735,524 in HIV-Positive Children and Adolescents
2. A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients
3. A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
4. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
5. A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Related Studies:
Other HIV Infections Clinical Trials
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Other New York City Clinical Trials
A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT
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