Cytomegalovirus RetinitisNCT00002299
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
A study testing Interferon beta-1b and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 6 sites in United States.
Trial summary
The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Interferon beta-1b and Ganciclovir
- How many people
- Not given
- Where
- 6 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained.
- Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed.
Who cannot join
- Co-existing Condition:
- Patients not meeting inclusion criteria are excluded.
- Patients not meeting inclusion criteria are excluded.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Univ TX Galveston Med Branch
Galveston, Texas, 77550
USC
Los Angeles, California, 90033
UCI Med Ctr
Orange, California, 92668
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
Stanford Univ School of Medicine
Stanford, California, 94305
About this study
Official title: Combination Therapy With 9-(1,3-Dihydroxy-2-Propoxymethyl) Guanine (DHPG) and Interferon Beta for the Prevention of Relapse of Cytomegalovirus Retinitis in Patients With the Acquired Immunodeficiency Syndrome
The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Interferon beta-1b, Ganciclovir
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Interferon Type I
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, AIDS-Related Opportunistic Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1bDrug
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 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002299
- Sponsor's protocol ID
- 017A
- Other IDs
- ICM 1285
- Status last verified
- Apr 1990
- 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
- Combination Therapy With 9-(1,3-Dihydroxy-2-Propoxymethyl) Guanine (DHPG) and Interferon Beta for the Prevention of Relapse of Cytomegalovirus Retinitis in Patients With the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002299
- Acronym / sponsor ID
- 017A
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Interferon Type I
- Study type
- Interventional
- Recruitment status
- Completed
- 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 use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained.
- Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed.
Key exclusion criteria (3 listed)
- Patients not meeting inclusion criteria are excluded.
- Patients not meeting inclusion criteria are excluded.
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 |
|---|---|---|
| Interferon beta-1b | 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon beta-1b and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Hoffmann-La Roche at 6 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 2 inclusion and 3 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 6 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?
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.