A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000729

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

10

Expected to finish

1992-06-01

Last updated by the study team

2021-11-03

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• USC School of Medicine / Norris Cancer Hosp — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• SUNY - Stony Brook — Stony Brook, New York, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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