Cytomegalovirus RetinitisPhase 3NCT00002377
A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 19 sites in 2 countries.
Trial summary
To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Valganciclovir and Ganciclovir
- How many people
- Not given
- Where
- 19 sitesin 2 countries
- Study dates
- Jan 1997to Dec 2002
- Phase
- Phase 3
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented AIDS diagnosis
- Newly diagnosed peripheral CMV retinitis
- More than 3 weeks of previous therapy for CMV retinitis
Who cannot join
None listed.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
Emory Eye Clinic
Atlanta, Georgia, 30322
Austin Infectious Disease Consultants
Austin, Texas, 78705
New England Med Ctr
Boston, Massachusetts, 02111
Duke Univ Eye Ctr
Durham, North Carolina, 27710
Univ of California / Irvine
Irvine, California, 92697
Univ of California / San Diego / Dept of Pediatrics
La Jolla, California, 92093
Univ of Miami School of Medicine
Miami, Florida, 33136
New York Univ Med Ctr
New York, New York, 10016
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York, New York, 10019
New York Hosp - Cornell Med Ctr
New York, New York, 10021
Univ of California / San Diego Treatment Ctr
San Diego, California, 92103
Davies Med Ctr / Institute for HIV Research
San Francisco, California, 94114
Kaiser Permanente Med Ctr
San Francisco, California, 94115
QUEST Clinical Research
San Francisco, California, 94115
Dr Alan Palestine
Washington D.C., District of Columbia, 20006
Canada4 sites
Montreal Chest Institute
Montreal, Quebec
Royal Victoria Hosp
Montreal, Quebec
The Toronto Hosp / Dept of Infectious Disease
Toronto, Ontario
St Pauls Hosp
Vancouver, British Columbia
About this study
To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Valganciclovir, Ganciclovir
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
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)
- Study startJan 1997
- Primary completionDec 2002
- Study completionDec 2002
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 Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002377
- Sponsor's protocol ID
- WV15376
- Status last verified
- Jul 2005
- First submitted
- 2 Nov 1999
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
- ClinicalTrials.gov ID
- NCT00002377
- Acronym / sponsor ID
- WV15376
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 1997 (actual)
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (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 investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Documented AIDS diagnosis
- Newly diagnosed peripheral CMV retinitis
- More than 3 weeks of previous therapy for CMV retinitis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Valganciclovir | 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 17 May 2017.
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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.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 19 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 3 inclusion and 0 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 May 2017.