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A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease Clinical research trials and A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease. A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease clinical trial. Participants frequently get the best healthcare available for their A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease  A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the toxicity of low dose foscarnet administered for 4 weeks to HIV infected patients who are asymptomatic, have AIDS, or other HIV associated conditions and a CD4+ lymphocyte count < 500 cells/mm3. To obtain preliminary efficacy data. Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS.
Details: Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Patients are divided into three groups: (1) asymptomatic patients with or without persistent generalized lymphadenopathy (PGL) syndrome; (2) patients with AIDS; and (3) patients who have or have had mild to moderate signs or symptoms consistent with HIV infection. Patients are then randomly chosen to receive one of three different foscarnet doses. The drug is given for 4 weeks, by 1-hour infusion administered every 8 hours. In addition, those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment, in the form of a single daily dose of foscarnet to be administered 5 days per week. Blood samples are taken during treatment and at the first, fourth, and eighth week after treatment. If the patient is on maintenance, blood samples are taken weekly. Effective 7-17-89, patients entering the study are assigned to the lowest foscarnet dose. Patients receive daily treatment for 28 days. Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine for secondary Pneumocystis carinii pneumonia (PCP) prophylaxis. - Short course therapy with oral acyclovir (ACV) = or < 7 days. Short course therapy with ketoconazole = or < 7 days for patients who are not responding to any other therapy. - Flurazepam. - Diphenhydramine. Prior Medication: Allowed: - Systemic therapy, prophylaxis or maintenance for an AIDS-defining opportunistic infection. Patients with any of the following findings may be included: - Asymptomatic HIV patients with or without lymphadenopathy. - Patients with AIDS as defined by the CDC surveillance case definitions. - Patients with past or present mild to moderate signs or symptoms consistent with HIV infection. - p24 antigen in the serum = or > 60 pg/ml. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: - Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Cytomegalovirus (CMV) retinitis. - AIDS dementia. Concurrent Medication: Excluded: - Antiretrovirals. - Immunomodulatory agents. - Corticosteroids Other systemic antiviral or antimicrobial agents. - Experimental medications. - Excluded on chronic basis and discouraged for > 72 hours: - Acetaminophen. - Narcotics. - Aspirin. Concurrent Treatment: Excluded: - Transfusion dependency or requirement of 2 units of blood more than once per month. Patients with the following will be excluded: - Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Cytomegalovirus (CMV) retinitis. - AIDS dementia. Prior Medication: Excluded within 30 days of study entry: - Antiretroviral agents (except ribavirin). - Immunomodulatory agents. - Excluded within 60 days of study entry: - Ribavirin. The last blood transfusion cannot have been given within 2 weeks of entry. Active substance abuse which could impair compliance with the protocol.
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
CollierAC, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Washington
Seattle, Washington, 98105
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 028;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000729
Other Hiv Infections Studies:
1. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
2. Effects of Ribavirin on Zidovudine or Stavudine
3. Directly Observed Therapy in HIV Infected Adolescent Focus Groups
4. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
5. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Related Studies:
Other HIV Infections Clinical Trials
Other South Carolina Clinical Trials
Other West Columbia Clinical Trials
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease
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