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HIV InfectionsPhase 1NCT00000729

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

A Phase 1 study testing Foscarnet sodium in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Foscarnet sodium
How many people
10 participants
Where
11 sitesUnited States
Study dates
Start not givento Jun 1992
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp

    Elmhurst, New York, 11373

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • USC School of Medicine / Norris Cancer Hosp

    Los Angeles, California, 90033

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • Univ of Washington

    Seattle, Washington, 98105

  • SUNY - Stony Brook

    Stony Brook, New York, 117948153

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

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.

Read the 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.

Conditions
HIV Infections
Being tested
Foscarnet sodium
Keywords
Virus Replication, Infusions, Intravenous, Dose-Response Relationship, Drug, Foscarnet, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, CD4-Positive T-Lymphocytes
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foscarnet sodiumDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionJun 1992

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Enrolment
10 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000729
Sponsor's protocol ID
ACTG 028
Other IDs
11004
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 7911290

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Foscarnet sodium in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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