NCT00000729

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

June 1, 1992

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Virus ReplicationInfusions, IntravenousDose-Response Relationship, DrugFoscarnetAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral AgentsCD4-Positive T-Lymphocytes

Interventions

Foscarnet sodiumDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, 90033, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

City Hosp Ctr at Elmhurst / Mount Sinai Hosp

Elmhurst, New York, 11373, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

SUNY - Stony Brook

Stony Brook, New York, 117948153, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • 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.

    PMID: 7911290BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Foscarnet

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganophosphonatesOrganophosphorus Compounds

Study Officials

  • Collier AC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

June 1, 1992

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

US(11)