Cytomegalovirus RetinitisPhase 4NCT00002125
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
A Phase 4 study testing Foscarnet sodium in people with Cytomegalovirus Retinitis and HIV Infections, run by Astra USA at 11 sites in United States.
Trial summary
To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Foscarnet sodium
- How many people
- 112 participants
- Where
- 11 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
- No corneal, lens, or vitreous opacification that precludes examination of the fundi.
- No evidence of other end organ CMV infection.
- No evidence of tuberculous, diabetic, or hypertensive retinopathy.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
- Known allergy to foscarnet or related compounds.
- Considered noncompliant or unreliable for study participation.
- Concurrent Medication:
Show all 13Show fewer
- Excluded:
- Any investigational drug.
- Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).
- Prior Medication:
- Excluded:
- Any investigational drug within 28 days prior to study entry.
- Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin) within 7 days prior to study entry.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309
Austin Infectious Disease Consultants
Austin, Texas, 78705
Dr Paul Benson
Berkley, Michigan, 48072
Dr Ralph Hansen
Beverly Hills, California, 90210
Dr John Karedes
Indianapolis, Indiana, 46204
Dr Milan Fiala
Los Angeles, California, 900246970
Dr G Michael Wool
Los Angeles, California, 90067
Dr Ronald J Grossman
New York, New York, 10016
AIDS Community Research Consortium
Redwood City, California, 94063
Community Health Network
Rochester, New York, 14620
Dr Ronald Nahass
Somerville, New Jersey, 08876
About this study
To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.
Read the detailed description
Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Foscarnet sodium
- Keywords
- Retinitis, Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Fluid Therapy
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foscarnet sodiumDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Enrolment
- 112 participants
Sponsor and investigators
- Lead sponsor
- Astra USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wool GM, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002125
- Sponsor's protocol ID
- 020H
- Other IDs
- 93-FOS-31
- Status last verified
- Jun 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
- ClinicalTrials.gov ID
- NCT00002125
- Acronym / sponsor ID
- 020H
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Fluid Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants
- Lead sponsor
- Astra USAIndustry (pharma, biotech, devices)
- 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 assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.
Detailed description
Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV infection.
- Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
- No corneal, lens, or vitreous opacification that precludes examination of the fundi.
- No evidence of other end organ CMV infection.
- No evidence of tuberculous, diabetic, or hypertensive retinopathy.
Key exclusion criteria (13 listed)
- Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
- Known allergy to foscarnet or related compounds.
- Considered noncompliant or unreliable for study participation.
- Any investigational drug.
- Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).
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 |
|---|---|---|
| Foscarnet sodium | 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 24 Jun 2005.
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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.
Wool GM study chair
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Foscarnet sodium in people with Cytomegalovirus Retinitis and HIV Infections, run by Astra USA at 11 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 6 inclusion and 13 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Jun 2005.