Cytomegalovirus InfectionsPhase 2NCT00000981
The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS
A Phase 2 study testing Fiacitabine in people with Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Cytomegalovirus Infections, HIV Infections
- What is being tested?
- Fiacitabine
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Feb 1993
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Natl Institute of Health
Bethesda, Maryland, 20892
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
Univ of Washington / Madison Clinic
Seattle, Washington, 98122
About this study
Official title: Efficacy and Safety of Oral FIAC in AIDS Patients With Cytomegalovirus Infection: A Dose Ranging Study
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.
Read the 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 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.
Patients are treated as outpatients if general health permits. This is continued for up to 90 days or until failure on basis of efficacy, tolerance, or toxicity. The dose escalation between groups of patients uses the formula n + 0.7n. Entry of new patients at the next higher dose is based on results of antiviral, tolerance, and safety data for the prior cohort when they have received at least 14 days of therapy. Consecutively qualifying patients are enrolled for each dose group and not based on either disease severity or expected tolerance. Although not formally randomized due to the sequential nature of the study and serious medical condition of the patients, every attempt to avoid bias in assigning a patient to a dose is made. Patients are advised to avoid heavy exercise within 24 hours of any laboratory tests.
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Being tested
- Fiacitabine
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Pyrimidine Nucleosides, Drug Evaluation, fiacitabine, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Medical subject headings
- Cytomegalovirus Infections, HIV Infections, Retinitis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiacitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Oclassen Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000981
- Sponsor's protocol ID
- ACTG 122 FIAC
- Other IDs
- R89-001-01, 02, 03, 04
- Status last verified
- Dec 2012
- First submitted
- 2 Nov 1999
- Last updated
- 18 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral FIAC in AIDS Patients With Cytomegalovirus Infection: A Dose Ranging Study
- ClinicalTrials.gov ID
- NCT00000981
- Acronym / sponsor ID
- ACTG 122 FIAC
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Pyrimidine Nucleosides, Drug Evaluation, fiacitabine, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Oclassen Pharmaceuticals
- Study completion
- Feb 1993 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Patients are treated as outpatients if general health permits. This is continued for up to 90 days or until failure on basis of efficacy, tolerance, or toxicity. The dose escalation between groups of patients uses the formula n + 0.7n. Entry of new patients at the next higher dose is based on results of antiviral, tolerance, and safety data for the prior cohort when they have received at least 14 days of therapy. Consecutively qualifying patients are enrolled for each dose group and not based on either disease severity or expected tolerance. Although not formally randomized due to the sequential nature of the study and serious medical condition of the patients, every attempt to avoid bias in assigning a patient to a dose is made. Patients are advised to avoid heavy exercise within 24 hours of any laboratory tests.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment.
- 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.
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiacitabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fiacitabine in people with Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.