ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000693
  Purpose

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.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Zidovudine
Drug: Acyclovir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Zidovudine    Acyclovir    Acyclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   25

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000693

Locations
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr    
      Chicago, Illinois, United States, 60612
Northwestern Univ Med School    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Investigators
Study Chair:     HA Kessler    
Study Chair:     CA Benson    
  More Information


Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
 
Click here for more information about Acyclovir  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   ACTG 070
First Received:   November 2, 1999
Last Updated:   August 25, 2008
ClinicalTrials.gov Identifier:   NCT00000693
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis  
Drug Evaluation  
Drug Therapy, Combination  
Cytomegalovirus Infections  
Acyclovir
Acquired Immunodeficiency Syndrome
Zidovudine

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Zidovudine
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
Acyclovir
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Eye Infections, Viral
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers