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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000729
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  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 1

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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 10
Study Completion Date: June 1992
Detailed Description:

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
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000729

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
Mount Sinai Med Ctr
New York, New York, United States, 10029
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
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
Sponsors and Collaborators
Investigators
Study Chair: Collier AC
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000729     History of Changes
Other Study ID Numbers: ACTG 028, 11004
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Virus Replication
Infusions, Intravenous
Dose-Response Relationship, Drug
Foscarnet
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
CD4-Positive T-Lymphocytes

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Foscarnet
Phosphonoacetic Acid
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014