Cytomegalovirus RetinitisPhase 4NCT00000894
Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
A Phase 4 study testing Cidofovir, Probenecid and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis. 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?
- Cidofovir, Probenecid and Ganciclovir
- How many people
- 300 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento Jun 2000
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are 13 years of age or older (parent or guardian consent required if under 18).
- Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
- Have AIDS.
- Have CMV retinitis.
Who cannot join
- You will not be eligible for this study if you:
- Have a history of heart or kidney disease.
- Have medical problems which would prevent you from completing the study.
- Are pregnant.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory Eye Clinic
Atlanta, Georgia, 30322
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ / SOCA
Chicago, Illinois, 60611
Univ of Texas Galveston
Galveston, Texas, 775550435
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Miami / Bascom Palmer Eye Institute
Miami, Florida, 33136
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Cornell Univ Med Ctr
New York, New York, 10021
New York Hosp / Cornell Med Ctr
New York, New York, 10021
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
Read the detailed description
While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.
After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Cidofovir, Probenecid, Ganciclovir
- Keywords
- Infusions, Intravenous, Ganciclovir, Drug Therapy, Combination, Administration, Oral, Antiviral Agents, Drug Implants, Cytomegalovirus Retinitis, Eye, cidofovir
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
ProbenecidDrug
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)
- Primary completionJun 2000
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 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000894
- Sponsor's protocol ID
- ACTG 350
- Status last verified
- Jun 2003
- First submitted
- 2 Nov 1999
- Last updated
- 23 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
- ClinicalTrials.gov ID
- NCT00000894
- Acronym / sponsor ID
- ACTG 350
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Infusions, Intravenous, Ganciclovir, Drug Therapy, Combination, Administration, Oral, Antiviral Agents, Drug Implants, Cytomegalovirus Retinitis, Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jun 2000 (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 compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
Detailed description
While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.
After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are 13 years of age or older (parent or guardian consent required if under 18).
- Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
- Have AIDS.
- Have CMV retinitis.
Key exclusion criteria (4 listed)
- Have a history of heart or kidney disease.
- Have medical problems which would prevent you from completing the study.
- Are pregnant.
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 |
|---|---|---|
| Cidofovir | Drug | – |
| Probenecid | 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 23 Feb 2011.
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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.
12 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 Cidofovir, Probenecid and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 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 5 inclusion and 4 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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 23 Feb 2011.