Cytomegalovirus RetinitisNCT00002134
A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
A study testing Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Roche Global Development at 23 sites in United States.
Trial summary
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. 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
- 450 participants
- Where
- 23 sitesUnited States
- 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 drugs and ophthalmics.
- Patients must have:
- AIDS.
- Unilateral CMV retinitis.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
- Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
- Acute retinal necrosis or any other intraocular condition that might preclude study completion.
- Ocular condition requiring immediate surgery.
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- Unable to have long-term IV catheter placement.
- Concurrent Medication:
- Excluded:
- Vidarabine.
- Amantadine hydrochloride.
- Cytarabine.
- FIAC or FIAU.
- Idoxuridine.
- Ribavirin.
- Valacyclovir.
- Foscarnet.
- CMV hyperimmune globulin.
- Soluble CD4.
- Trichosanthin.
- Imipenem-cilastatin.
- Isoprinosine.
- Levamisole.
- Interferon.
- Other investigational drugs.
- Patients with the following prior conditions are excluded:
- History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
- History of hypersensitivity to acyclovir or ganciclovir.
- Prior Medication:
- Excluded:
- Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
- Prior intravitreal ganciclovir implant.
- More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
- Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory Eye Clinic
Atlanta, Georgia, 30322
Dr Neil Brourman
Beverly Hills, California, 90211
New England Med Ctr / Tufts Univ
Boston, Massachusetts, 02111
Dr David Weinberg
Chicago, Illinois, 60611
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77030
UCI College of Medicine
Irvine, California, 92715
Dr Michael Stewart
Jacksonville, Florida, 32204
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
Estelle Doheny Eye Clinic
Los Angeles, California, 90033
Bascom Palmer
Miami, Florida, 33136
Dr Dorothy Friedberg
New York, New York, 10016
Saint Clare's Prof Office
New York, New York, 10019
New York Hosp
New York, New York, 10021
Vitreo - Retinal Consultants
New York, New York, 10028
Dr Robert T Wendel
Sacramento, California, 95819
Kaiser Hosp
San Francisco, California, 94115
Pacific Horizons Med Group
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 95128
Dr Robert Avery
Santa Barbara, California, 93103
Univ of Washington Med Ctr
Seattle, Washington, 98195
Harbor - UCLA Med Ctr
Torrance, California, 90509
Dr Alan Palestine
Washington D.C., District of Columbia, 20036
About this study
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Read the detailed description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, 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
- 450 participants
Sponsor and investigators
- Lead sponsor
- Roche Global Development
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002134
- Sponsor's protocol ID
- 037B
- Other IDs
- GANS2304
- Status last verified
- Jul 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.
PubMed 11363508
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, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
- ClinicalTrials.gov ID
- NCT00002134
- Acronym / sponsor ID
- 037B
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 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 demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Detailed description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
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 (6 listed)
- Topical drugs and ophthalmics.
- AIDS.
- Unilateral CMV retinitis.
Key exclusion criteria (34 listed)
- Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
- Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
- Acute retinal necrosis or any other intraocular condition that might preclude study completion.
- Ocular condition requiring immediate surgery.
- Unable to have long-term IV catheter placement.
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.
- Background: PubMed 11363508Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.
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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.
23 sites in 1 country: 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 23 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 34 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 23 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.
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 NCT00002134, 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.