The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS

NCT00000981 | Completed Phase 2

• 2 other identifiers: ACTG 122 FIACR89-001-01, 02, 03, 04
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

Brief Summary

To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics following multiple doses of FIAC. (An example of another nucleoside analog effective against retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant opportunistic disease in patients with HIV-related infection. The purine nucleoside ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is useful in treating CMV disease, such treatment is frequently complicated by hematologic (blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing. Test tube studies show that FIAC and its primary breakdown product FIAU are highly and specifically active against several viruses including CMV. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU.

Conditions

Cytomegalovirus Infections; HIV Infections

Keywords

Retinitis; AIDS-Related Opportunistic Infections; Pyrimidine Nucleosides; Drug Evaluation; fiacitabine; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents

Interventions

Fiacitabine DRUG

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment.
• Prior Medication:
• Allowed:
• Zidovudine (AZT) but only if patient has been taking the drug for \> 6 weeks at a dose = or \< 600 mg/day, and had \< 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for \> 1 month.
• Patients must:
• Have documented cytomegalovirus (CMV) viremia or viruria.
• Have a diagnosis of HIV infection by ELISA or Western blot.
• Be able to participate as an outpatient.
• Be ambulatory.
• Grade 0 or 1 AIDS Clinical Trial Group toxicity grades for specified laboratory tests.
• Be competent to sign informed consent.
• Be able to cooperate with the treatment plan and evaluation schedule.
• NOTE:

You may not qualify if:

• Co-existing Condition:
• Patients with the following are excluded:
• HIV wasting syndrome (involuntary weight loss \> 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days).
• Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.
• Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.
• Cytomegalovirus end organ disease.
• Kaposi's sarcoma requiring chemotherapy.
• Systemic fungal infection requiring amphotericin therapy.
• Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts \< 100000 platelets/mm3 for = or \> 3 months).
• Patients with the following are excluded:
• HIV wasting syndrome.
• Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.
• Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.
• Cytomegalovirus (CMV) end organ disease e.g., retinitis, hepatitis, gastroenteritis.
• Prior Medication:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Oclassen Pharmaceuticals: collaborator

Study Sites (4)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Natl Institute of Health

Bethesda, Maryland, 20892, United States

Location

Univ of Washington / Madison Clinic

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; HIV Infections; Retinitis; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

fiacitabine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Retinal Diseases; Eye Diseases; Opportunistic Infections; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1993
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

US (4)