A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
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| ClinicalTrials.gov Identifier: NCT00000729 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Foscarnet sodium | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 10 participants |
| 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 |
| Actual Study Completion Date : | June 1992 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000729
| 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 |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000729 |
| Other Study ID Numbers: |
ACTG 028 11004 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 3, 2021 |
| Last Verified: | October 2021 |
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Virus Replication Infusions, Intravenous Dose-Response Relationship, Drug Foscarnet |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents CD4-Positive T-Lymphocytes |
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Foscarnet Phosphonoacetic Acid Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |