Cytomegalovirus RetinitisPhase 2NCT00002156
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
A Phase 2 study testing Fomivirsen sodium and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Ionis Pharmaceuticals, Inc. at 18 sites in United States.
Trial summary
To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis. 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?
- Fomivirsen sodium and Ganciclovir
- How many people
- 194 participants
- Where
- 18 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- AIDS.
- CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
- No more than one previous progression of CMV retinitis.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions in the eye to be treated are excluded:
- External ocular infection.
- Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
- Ocular condition that will obstruct visualization of the posterior ocular structures.
- Retinal detachment.
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- Silicone oil in eye.
- Patients with the following other symptoms or conditions are excluded:
- Known or suspected allergy to phosphorothioate oligonucleotides.
- Syphilis.
- Retinal pigment epithelial stippling not associated with CMV retinitis.
- Pseudoretinitis pigmentosa.
- Chronic diarrhea that would impair absorption of oral ganciclovir.
- Intolerance to ganciclovir.
- Concurrent Medication:
- Excluded:
- Foscarnet or other anti-CMV agents other than ganciclovir.
- Mellaril.
- Stelazine.
- Thorazine.
- Clofazimine.
- Ethambutol/fluconazole combination.
- Investigational medications for CMV retinitis.
- Concurrent Treatment:
- Excluded:
- Investigational procedures for CMV retinitis.
- Patients with the following prior conditions are excluded:
- History of surgery to correct retinal detachment in eye to be treated.
- History of intolerance to ISIS 2922.
- Prior Medication:
- Excluded:
- Prior ganciclovir implant for CMV retinitis.
- More than 4 months of prior ganciclovir.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Georgia Retina
Atlanta, Georgia, 30327
Charlotte Eye Ear Nose and Throat Association
Charlotte, North Carolina, 28204
Univ of Illinois
Chicago, Illinois, 60612
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359057
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Dr Julio Perez
Fort Lauderdale, Florida, 33060
Baylor College of Medicine
Houston, Texas, 77030
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017
Vitreo - Retinal Consultants
New York, New York, 10028
Virginia Eye Consultants
Norfolk, Virginia, 23507
Community Eye Med Group
Pasadena, California, 911052536
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
Graduate Hosp
Philadelphia, Pennsylvania, 191461192
San Diego Naval Hosp
San Diego, California, 92134
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110
Santa Clara Valley Med Ctr
San Jose, California, 95128
Novum Inc
Seattle, Washington, 98104
About this study
To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.
Read the detailed description
In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Fomivirsen sodium, Ganciclovir
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis, Injections
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, AIDS-Related Opportunistic Infections, 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.
Fomivirsen sodiumDrug
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.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.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
- Masking
- None (open label)
- Enrolment
- 194 participants
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002156
- Sponsor's protocol ID
- 251B
- Other IDs
- ISIS 2922-CS3
- Status last verified
- Dec 1998
- 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 Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
- ClinicalTrials.gov ID
- NCT00002156
- Acronym / sponsor ID
- 251B
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis, Injections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (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 determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.
Detailed description
In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AIDS.
- CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
- No more than one previous progression of CMV retinitis.
Key exclusion criteria (33 listed)
- External ocular infection.
- Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
- Ocular condition that will obstruct visualization of the posterior ocular structures.
- Retinal detachment.
- Silicone oil in eye.
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 |
|---|---|---|
| Fomivirsen sodium | Drug | – |
| 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.
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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.
18 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 Fomivirsen sodium and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Ionis Pharmaceuticals, Inc. at 18 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 4 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 18 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 24 Jun 2005.