Cytomegalovirus RetinitisPhase 3NCT00017784
Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
A Phase 3 study testing Valganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 9 sites in 2 countries.
Trial summary
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy. 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?
- Valganciclovir
- How many people
- 500 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are 18 years of age or older.
- Are HIV-positive.
- Have active CMV retinitis, shown by an eye exam by an eye doctor, that needs treatment.
- Have had problems when drugs were given by injection, such as difficulty in finding a vein or problems (blood clots, vein inflammation, or infection) caused by injection devices.
- Agree to use effective methods of birth control (i.e., barrier methods) during the study and for 90 days after taking the study drug. Females who can have children must have a negative pregnancy test before entering the study.
- Stop breast-feeding before starting the study drug.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have developed CMV retinitis after a transplant.
- Have kidney disease and need hemodialysis.
- Are taking part in another drug study, unless approved by the study doctor.
- Take experimental drugs, or have taken them within 30 days before study entry, unless approved by the study doctor.
- Take drugs not allowed on the study, including foscarnet, cidofovir, and probenecid.
- Are not able to follow study procedures, including visits to the eye doctor and the study doctor.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309
Retina - Vitreous Associates Med Group
Beverly Hills, California, 90211
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, 37203
Wilbert Jordan
Paramount, California, 90723
Quest Clinical Research
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 95128
About this study
Official title: Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy.
CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective against CMV eye infections can be given only by injection; this calls for a thin tube to be placed into a vein in the chest so that the patient is not put through getting too many needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.
Read the detailed description
CMV causes sight- or life-threatening opportunistic infections in people with AIDS. Intravenous agents including ganciclovir, foscarnet, and cidofovir are presently approved as treatments for CMV retinitis within this population. Ganciclovir and foscarnet induction and maintenance therapy require daily infusions and usually require the use of long-term indwelling central venous catheters. Although the treatment interval of cidofovir is longer, administration necessitates the use of pre-hydration and probenecid in order to avoid a risk of renal toxicity. Oral ganciclovir is an alternative to the intravenous formulation for the maintenance treatment of CMV retinitis. However, because blood levels achieved after oral ganciclovir are low compared to intravenous, oral ganciclovir cannot be used for induction therapy. In an attempt to improve the bioavailability of ganciclovir, valganciclovir was developed. Valganciclovir is a ganciclovir prodrug which, when administered orally, is rapidly converted to the active compound ganciclovir during a first-pass process, with the majority of hydrolysis occurring pre-systemically. Studies have shown that valganciclovir tablets allow systemic exposure of ganciclovir comparable to that achieved with recommended doses of intravenous ganciclovir.
Patients undergo an ophthalmologic exam by an ophthalmologist and safety and other laboratory tests to establish eligibility. No specific visits are requested by the drug usage plan following enrollment; however, patients should be seen for safety and/or clinical assessments and medication dispensation at periodic visits, consistent with standard of care. An ophthalmologic exam should be performed again at Week 3 (no later than Week 4), at the end of the induction treatment phase consistent with standard of care in order to ensure adequate response to therapy. Valganciclovir is provided on a monthly basis and only as long as the patient is assessed and information provided in a timely manner. This supply will be terminated 1 month subsequent to when the drug is available by prescription, unless otherwise decided.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Valganciclovir
- Keywords
- AIDS-Related Opportunistic Infections, Infusions, Intravenous, Antiviral Agents, Cytomegalovirus Retinitis, valganciclovir
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
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 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
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017784
- Sponsor's protocol ID
- 268C
- Other IDs
- ML16356
- Status last verified
- Jun 2001
- First submitted
- 11 Jun 2001
- 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
- Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment
- ClinicalTrials.gov ID
- NCT00017784
- Acronym / sponsor ID
- 268C
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Infusions, Intravenous, Antiviral Agents, Cytomegalovirus Retinitis, valganciclovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (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.
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy.
CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective against CMV eye infections can be given only by injection; this calls for a thin tube to be placed into a vein in the chest so that the patient is not put through getting too many needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.
Detailed description
CMV causes sight- or life-threatening opportunistic infections in people with AIDS. Intravenous agents including ganciclovir, foscarnet, and cidofovir are presently approved as treatments for CMV retinitis within this population. Ganciclovir and foscarnet induction and maintenance therapy require daily infusions and usually require the use of long-term indwelling central venous catheters. Although the treatment interval of cidofovir is longer, administration necessitates the use of pre-hydration and probenecid in order to avoid a risk of renal toxicity. Oral ganciclovir is an alternative to the intravenous formulation for the maintenance treatment of CMV retinitis. However, because blood levels achieved after oral ganciclovir are low compared to intravenous, oral ganciclovir cannot be used for induction therapy. In an attempt to improve the bioavailability of ganciclovir, valganciclovir was developed. Valganciclovir is a ganciclovir prodrug which, when administered orally, is rapidly converted to the active compound ganciclovir during a first-pass process, with the majority of hydrolysis occurring pre-systemically. Studies have shown that valganciclovir tablets allow systemic exposure of ganciclovir comparable to that achieved with recommended doses of intravenous ganciclovir.
Patients undergo an ophthalmologic exam by an ophthalmologist and safety and other laboratory tests to establish eligibility. No specific visits are requested by the drug usage plan following enrollment; however, patients should be seen for safety and/or clinical assessments and medication dispensation at periodic visits, consistent with standard of care. An ophthalmologic exam should be performed again at Week 3 (no later than Week 4), at the end of the induction treatment phase consistent with standard of care in order to ensure adequate response to therapy. Valganciclovir is provided on a monthly basis and only as long as the patient is assessed and information provided in a timely manner. This supply will be terminated 1 month subsequent to when the drug is available by prescription, unless otherwise decided.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are 18 years of age or older.
- Are HIV-positive.
- Have active CMV retinitis, shown by an eye exam by an eye doctor, that needs treatment.
- Have had problems when drugs were given by injection, such as difficulty in finding a vein or problems (blood clots, vein inflammation, or infection) caused by injection devices.
- Agree to use effective methods of birth control (i.e., barrier methods) during the study and for 90 days after taking the study drug. Females who can have children must have a negative pregnancy test before entering the study.
Key exclusion criteria (8 listed)
- Are pregnant or breast-feeding.
- Have developed CMV retinitis after a transplant.
- Have kidney disease and need hemodialysis.
- Are taking part in another drug study, unless approved by the study doctor.
- Take experimental drugs, or have taken them within 30 days before study entry, unless approved by the study doctor.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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.
9 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 in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 9 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 7 inclusion and 8 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: status not confirmed, 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 9 sites in United States, Puerto Rico. 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?
Results are not available in the source record.
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; AzTrials last refreshed its copy on 7 Nov 2026.