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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000729 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Foscarnet sodium |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease |
| Estimated Enrollment: | 10 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Prior Medication:
Allowed:
Patients with any of the following findings may be included:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following will be excluded:
Prior Medication:
Excluded within 30 days of study entry:
The last blood transfusion cannot have been given within 2 weeks of entry.
Active substance abuse which could impair compliance with the protocol.
Contacts and Locations| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| USC School of Medicine / Norris Cancer Hosp | |
| Los Angeles, California, United States, 90033 | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, Ohio | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98105 | |
| Study Chair: | Collier AC |
More Information
| ClinicalTrials.gov Identifier: | NCT00000729 History of Changes |
| Other Study ID Numbers: | ACTG 028 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Virus Replication Infusions, Intravenous Dose-Response Relationship, Drug Foscarnet |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents CD4-Positive T-Lymphocytes |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Foscarnet Phosphonoacetic Acid Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
