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Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Acyclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Drug Evaluation, Drug Therapy, Combination, Cytomegalovirus Infections, Acyclovir, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Prior Medication: Required: Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction. Amended to allow: Investigational triazoles. Human recombinant erythropoietin (Eprex). Other investigational non-antiviral therapies offered through treatment IND. Patients must: Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye. Be capable of signing an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Known or suspected allergy to one of the study medications. Inability to maintain adequate hydration status. Concurrent Medication: Excluded: Concurrent therapy with nephrotoxic agents. Systemic therapy for another opportunistic infection. Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP). Probenecid. Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments. Patients with the following are excluded: Known or suspected allergy to one of the study medications. Inability to maintain adequate hydration status. Prior Medication: Excluded within 2 weeks of study entry: Steroids. Cytotoxic or immunosuppressive drugs. Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir). Prior Treatment: Excluded within 2 weeks of study entry: Radiotherapy. Risk Behavior: Excluded: History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.

Sites / Locations

  • Northwestern Univ Med School
  • Rush Presbyterian - Saint Luke's Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000693
Brief Title
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Official Title
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) count (leukopenia) which is a known side effect of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT, the only antiviral drug currently available for the treatment of HIV infection. Therefore, patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together. This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight. An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT. ACV is presently the drug of choice for severe herpes virus infections. It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants.
Detailed Description
CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) count (leukopenia) which is a known side effect of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT, the only antiviral drug currently available for the treatment of HIV infection. Therefore, patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together. This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight. An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT. ACV is presently the drug of choice for severe herpes virus infections. It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants. Patients receive ACV intravenously and AZT orally for 12 weeks. Tolerance of the combined administration of ACV and AZT is monitored. AMENDED: AZT dose lowered and inclusion of concurrent medication expanded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Drug Evaluation, Drug Therapy, Combination, Cytomegalovirus Infections, Acyclovir, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Prior Medication: Required: Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction. Amended to allow: Investigational triazoles. Human recombinant erythropoietin (Eprex). Other investigational non-antiviral therapies offered through treatment IND. Patients must: Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye. Be capable of signing an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Known or suspected allergy to one of the study medications. Inability to maintain adequate hydration status. Concurrent Medication: Excluded: Concurrent therapy with nephrotoxic agents. Systemic therapy for another opportunistic infection. Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP). Probenecid. Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments. Patients with the following are excluded: Known or suspected allergy to one of the study medications. Inability to maintain adequate hydration status. Prior Medication: Excluded within 2 weeks of study entry: Steroids. Cytotoxic or immunosuppressive drugs. Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir). Prior Treatment: Excluded within 2 weeks of study entry: Radiotherapy. Risk Behavior: Excluded: History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HA Kessler
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CA Benson
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1654361
Citation
Sha BE, Benson CA, Deutsch TA, Urbanski PA, Phair JP, Kessler HA. Suppression of cytomegalovirus retinitis in persons with AIDS with high-dose intravenous acyclovir. J Infect Dis. 1991 Oct;164(4):777-80. doi: 10.1093/infdis/164.4.777.
Results Reference
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Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

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