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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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