Foscarnet for suppression of human immunodeficiency virus replication.
C V Fletcher, A C Collier, F S Rhame...
https://pubmed.ncbi.nlm.nih.gov/7911290Completed
Phase 1
Age: 13Years +
All Genders
ID00000729
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
10
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 11 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
Status Unknown
3
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
4
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
5
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States, 11373
Status Unknown
6
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
7
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
8
SUNY - Stony Brook
Stony Brook, New York, United States, 117948153
Status Unknown
9
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
10
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
11
Univ of Washington
Seattle, Washington, United States, 98105
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
RANDOMIZED
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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