Cytomegalovirus RetinitisNCT00002330
A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
A study testing Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Roche Global Development at 36 sites in 2 countries.
Trial summary
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Ganciclovir
- How many people
- 280 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Topical and ophthalmic nucleoside analogues.
- Patients must have:
- HIV positive.
- No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
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- Currently stable retinitis.
- Prior Medication:
- Allowed:
- Foscarnet prior to the 4 weeks of intravenous induction therapy.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Persistent or clinically significant diarrhea, nausea, or abdominal pain.
- Severe odynophagia.
- Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
- Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
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- Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
- Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
- Concurrent Medication:
- Excluded:
- Acyclovir sodium (Zovirax) by any route other than topical.
- Valacyclovir.
- Brovavir.
- Vidarabine.
- Amantadine hydrochloride.
- Cytarabine.
- Idoxuridine.
- Ribavirin.
- Interferon.
- Foscarnet (non-nucleoside pyrophosphate analogue).
- CMV hyperimmune globulin.
- Soluble CD4.
- Trichosanthin (Compound Q).
- Imipenem-cilastatin.
- Isoprinosine.
- Levamisole.
- Other investigational drugs.
- Patients with the following prior condition are excluded:
- History of hypersensitivity to acyclovir or ganciclovir.
- Prior Medication:
- Excluded:
- More than three induction regimens with intravenous anti-CMV therapy.
- Any prior oral ganciclovir.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
Univ of New Mexico
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Austin Infectious Disease Consultants
Austin, Texas, 78705
Univ of Maryland School of Medicine
Baltimore, Maryland, 21201
East Bay AIDS Ctr
Berkeley, California, 94705
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
Nalle Clinic
Charlotte, North Carolina, 282072198
Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Hosp
Columbus, Ohio, 432101228
Community Research Initiative
Coral Gables, Florida, 33146
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
Dr Daniel Barbero
Fort Worth, Texas, 76104
Margo Heath - Chiozzi
Honolulu, Hawaii, 96816
Infectious Diseases Association of Houston
Houston, Texas, 77030
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
Dr Dorothy Friedberg
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
New York Hosp - Cornell Med Ctr
New York, New York, 10021
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
McDowell Clinic
Phoenix, Arizona, 85006
Dr Ken Fisher
Phoenix, Arizona, 85013
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
UCSD Med Ctr / Pediatrics
San Diego, California, 92103
Davies Med Ctr
San Francisco, California, 94114
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
AIDS Wellness Clinic
Sante Fe, New Mexico, 87501
AIDS Clinical Trials Unit
St Louis, Missouri, 63108
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
Associates Med and Mental Health
Tulsa, Oklahoma, 74114
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Read the detailed description
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- Retinitis, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Roche Global Development
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002330
- Sponsor's protocol ID
- 059F
- Other IDs
- GANs2226
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)
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 Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS
- ClinicalTrials.gov ID
- NCT00002330
- Acronym / sponsor ID
- 059F
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- Roche Global DevelopmentUniversity, hospital or other
- 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 compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Detailed description
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Topical and ophthalmic nucleoside analogues.
- HIV positive.
- No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
- Currently stable retinitis.
- Foscarnet prior to the 4 weeks of intravenous induction therapy.
Key exclusion criteria (33 listed)
- Persistent or clinically significant diarrhea, nausea, or abdominal pain.
- Severe odynophagia.
- Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
- Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
- Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
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 |
|---|---|---|
| Ganciclovir | 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.
- BackgroundLalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)
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Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
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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.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Roche Global Development at 36 sites in 2 countries.
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 10 inclusion and 33 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 36 sites in United States, Canada. 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.
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?
On the ClinicalTrials.gov record for NCT00002330, which also lists 1 linked publication.
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.