Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
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| ClinicalTrials.gov Identifier: NCT00000726 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cytomegalovirus Retinitis HIV Infections | Drug: Foscarnet sodium | Phase 1 |
Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against HIV.
Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by randomization to daily maintenance foscarnet for 8 weeks. If induction therapy is tolerated without unexpected toxicity, patients are allowed to self-administer foscarnet at home via central venous catheter and may receive up to 11 days of induction therapy by self-administration on an outpatient basis. Foscarnet will be administered in open-label fashion so that both investigator and patient will know the dose. Within the study, there are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with zidovudine (AZT).
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 53 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome |
| Actual Study Completion Date : | February 1992 |
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| Ages Eligible for Study: | 13 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Exclusion Criteria
Concurrent Medication:
Excluded:
- Acyclovir.
- Zidovudine (AZT).
- Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B.
Prior Medication:
Excluded:
- Ganciclovir.
- Foscarnet.
- Excluded within 7 days of study entry:
- Any potentially nephrotoxic agent.
- Excluded within 14 days of study entry:
- Cytomegalovirus hyperimmune globulin in therapeutic doses.
- Immunomodulators.
- Biologic response modifiers.
- Investigational agents.
- Amphotericin B maintenance for a systemic mycosis.
Known allergy to foscarnet.
Active AIDS-defining opportunistic infection other than cytomegalovirus (CMV) including systemic mycosis, pulmonary or neurologic impairment (comatose).
Patient must be diagnosed as having:
- AIDS CDC Group IV.C.
- Cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.
- One pending culture for CMV from blood and urine prior to study entry.
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): NCT00000726
| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| USC School of Medicine / Norris Cancer Hosp | |
| Los Angeles, California, United States, 90033 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| United States, New York | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Study Chair: | Jacobson M |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000726 |
| Other Study ID Numbers: |
ACTG 015 FDA 20D 10991 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 3, 2021 |
| Last Verified: | October 2021 |
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Retinitis AIDS-Related Opportunistic Infections Foscarnet |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents |
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Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Immunologic Deficiency Syndromes Pathologic Processes Disease Attributes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Immune System Diseases Slow Virus Diseases Retinal Diseases Eye Diseases Eye Infections, Viral Eye Infections Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Foscarnet Phosphonoacetic Acid Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors |