Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Oclassen Pharmaceuticals

Conditions:

Cytomegalovirus Infections

HIV Infections

Eligibility:

All Genders

13-65 years

Phase:

PHASE2

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 o...

Detailed Description

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...

Eligibility Criteria

Inclusion Criteria

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:

  • The screening tests must be initiated and completed within 4 weeks prior to the first dose of FIAC.

Concomitant diseases allowed:

  • Stable mucocutaneous Kaposi's sarcoma.
  • Superficial or uncomplicated infections such as thrush.

Exclusion Criteria

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:

Excluded within 4 weeks of study entry:

  • Zidovudine (AZT).
  • Acyclovir.
  • Ganciclovir (DHPG).
  • Foscarnet.
  • Interferon.
  • Other drug with putative anticytomegaloviral activity.
  • Any immunostimulating drug not specifically allowed.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1993

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT00000981

End Date

February 1 1993

Last Update

December 18 2012

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

3

Natl Institute of Health

Bethesda, Maryland, United States, 20892

4

Univ of Washington / Madison Clinic

Seattle, Washington, United States, 98122