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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002299 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Interferon beta-1b Drug: Ganciclovir |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
Exclusion Criteria
Co-existing Condition:
Patients not meeting inclusion criteria are excluded.
Patients not meeting inclusion criteria are excluded.
Contacts and Locations| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| USC | |
| Los Angeles, California, United States, 90033 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Stanford Univ School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
More Information
| Study ID Numbers: | 017A, ICM 1285 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002299 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Drug Therapy, Combination |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Interferon Type I |
|
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Slow Virus Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections |
Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Growth Substances Eye Diseases Interferons Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Adjuvants, Immunologic Interferon-beta Ganciclovir Angiogenesis Inhibitors Antiviral Agents |
