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

• Status: Completed
• Trial end date: 1992-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Foscarnet; Phosphonoacetic Acid

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.