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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

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.

City, postcode or hospital

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

Other trials in United States

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

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
CMV Retinitis
RecruitingEarly Phase 1
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Cytomegalovirus Retinitis, Ganciclovir Eye Drops

All Cytomegalovirus Retinitis trials