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


Phase 1
13 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Collier AC

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 028

NCT ID:

NCT00000729

Start Date:

Completion Date:

June 1992

Related Keywords:

  • HIV Infections
  • Virus Replication
  • Infusions, Intravenous
  • Dose-Response Relationship, Drug
  • Foscarnet
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • CD4-Positive T-Lymphocytes
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Julio ArroyoWest Columbia, South Carolina  29169
Los Angeles County - USC Med CtrLos Angeles, California  90033
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
Univ of MinnesotaMinneapolis, Minnesota  55455
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Mount Sinai Med CtrNew York, New York  10029
SUNY - Stony BrookStony Brook, New York  117948153
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Univ of WashingtonSeattle, Washington  98105
USC School of Medicine / Norris Cancer HospLos Angeles, California  90033