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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Foscarnet sodium
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Virus Replication, Infusions, Intravenous, Dose-Response Relationship, Drug, Foscarnet, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, CD4-Positive T-Lymphocytes

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • USC School of Medicine / Norris Cancer Hosp
  • Univ of California / San Diego Treatment Ctr
  • Univ of Minnesota
  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  • Mem Sloan - Kettering Cancer Ctr
  • Mount Sinai Med Ctr
  • SUNY - Stony Brook
  • Ohio State Univ Hosp Clinic
  • Julio Arroyo
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000729
Brief Title
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
Official Title
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Virus Replication, Infusions, Intravenous, Dose-Response Relationship, Drug, Foscarnet, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, CD4-Positive T-Lymphocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Allocation
Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Collier AC
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC School of Medicine / Norris Cancer Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7911290
Citation
Fletcher CV, Collier AC, Rhame FS, Bennett D, Para MF, Beatty CC, Jones CE, Balfour HH Jr. Foscarnet for suppression of human immunodeficiency virus replication. Antimicrob Agents Chemother. 1994 Mar;38(3):604-7. doi: 10.1128/AAC.38.3.604.
Results Reference
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A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

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