The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT00000654
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
• Scientific title: The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
• Target sample size: 78
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000654
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: D Richman

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP)
in patients currently receiving such treatment.

- Zidovudine (AZT).

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.

Patients must:

- Have a diagnosis of HIV infection by ELISA or Western blot. Be able to participate as
an outpatient.

- Be ambulatory.

- Have 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 FIAU, except for diagnostic herpes simplex virus (HSV), varicella zoster
(VZV), or cytomegalovirus (CMV) cultures which may have been done previously.

- Concomitant diseases allowed:

- Stable mucocutaneous disease.

- 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 infections or cardiovascular,
oncologic, renal, or hepatic condition.

- Primary or initial infection with herpes simplex (HSV), varicella zoster (VZV), or
hepatitis B (HBV).

- Cytomegalovirus (CMV) 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, infections,
oncologic, renal, or hepatic condition.

- Primary or initial infection with herpes simplex (HSV), varicella zoster (VZV), or
hepatitis B (HBV).

- Cytomegalovirus (CMV) end organ disease.

Prior Medication:

Excluded within 4 weeks of study entry:

- Ganciclovir (DHPG).

- Foscarnet.

- Interferon.

- Other drug with putative antiviral activity (except zidovudine (AZT)).

- Any immunostimulating drug not specifically allowed.

Excluded within 1 week of study entry:

- Acyclovir.



Age minimum: 13 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B

Herpes Simplex

HIV Infections

Intervention(s)

Drug: Fialuridine

Secondary ID(s)

ACTG 122 FIAU

R90-001-01, 02, 03, 04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oclassen Pharmaceuticals