Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
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| ClinicalTrials.gov Identifier: NCT00000894 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : February 23, 2011
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To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cytomegalovirus Retinitis HIV Infections | Drug: Cidofovir Drug: Probenecid Drug: Ganciclovir | Phase 4 |
While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.
After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 300 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| Official Title: | Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) |
| Actual Primary Completion Date : | June 2000 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
- Are 13 years of age or older (parent or guardian consent required if under 18).
- Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
- Have AIDS.
- Have CMV retinitis.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of heart or kidney disease.
- Have medical problems which would prevent you from completing the study.
- Are pregnant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000894
| United States, California | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Univ of Miami / Bascom Palmer Eye Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory Eye Clinic | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern Univ / SOCA | |
| Chicago, Illinois, United States, 60611 | |
| United States, Louisiana | |
| Charity Hosp / Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| New York Hosp / Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| ClinicalTrials.gov Identifier: | NCT00000894 History of Changes |
| Other Study ID Numbers: |
ACTG 350 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | February 23, 2011 |
| Last Verified: | June 2003 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Infusions, Intravenous Ganciclovir Drug Therapy, Combination Administration, Oral Antiviral Agents |
Drug Implants Cytomegalovirus Retinitis Eye cidofovir |
Additional relevant MeSH terms:
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Cytomegalovirus Infections HIV Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Retinal Diseases Eye Diseases Herpesviridae Infections |
DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Cidofovir Ganciclovir triphosphate Probenecid Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Uricosuric Agents Gout Suppressants Antirheumatic Agents |