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A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002

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: NCT00000682
  Purpose

To evaluate the efficacy of AZT versus ddC in terms of survival, antiviral effects, neurological status, and health status in patients post Pneumocystis carinii pneumonia (PCP) who received long-term AZT therapy in ACTG protocol 002 While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Zalcitabine
Phase III

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Zidovudine    Zalcitabine    Calcium polystyrene sulfonate    Polystyrene sulfonic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002

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

Estimated Enrollment:   120

Detailed Description:

While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients.

Following tests to evaluate their health, patients are chosen at random to receive either AZT or ddC. AZT is given by mouth at the patients' current dose. ddC is given by mouth every 8 hours. Treatment continues for up to 12 months. Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month. Blood samples are taken to monitor the safety and effectiveness of treatment.

  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Required:

  • Prior zidovudine (AZT) therapy for 9 months.

Concurrent Medication:

Allowed:

  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer.
  • Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, or inhaled pentamidine for subjects who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes infection, or PCP.
  • Dapsone for PCP.
  • Pyrimethamine-sulfadoxine for toxoplasmosis.
  • Ganciclovir (DHPG) for maintenance only for cytomegalovirus (CMV) retinitis.
  • Note: Any approved medications can be used to treat an opportunistic infection. All concurrent medications should be kept to a minimum and recorded.

Patients must be positive for HIV by ELISA test and must have been receiving zidovudine (AZT) therapy for at least 9 months and have received AZT within 90 days prior to entry into the study.

Patients may be transfusion dependent as long as no more than 3 units of blood are needed in a 21-day period and the hemoglobin does not fall below 6.4 g/dl on two consecutive occasions despite the transfusions.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers.
  • Corticosteroids and chronic aspirin.
  • Cimetidine.
  • Flurazepam.
  • Indomethacin.
  • Ranitidine.
  • Probenecid.
  • Other experimental medications.

Patients will be excluded from the study for the following reasons:

  • Removal from zidovudine (AZT) during treatment on ACTG protocol 002 for recurrent grade 4 toxicity.
  • Removal from prior dideoxycytidine (ddC) therapy for peripheral neuropathy = or > grade 3.
  • Visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.
  • Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).

Prior Medication:

Excluded:

  • Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers.
  • Patients may not have visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000682

Locations
United States, California
Univ of California / San Diego Treatment Ctr    
      San Diego, California, United States, 921036325
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
United States, Florida
Univ of Miami School of Medicine    
      Miami, Florida, United States, 331361013
United States, Illinois
Northwestern Univ Med School    
      Chicago, Illinois, United States, 60611
United States, Louisiana
Charity Hosp / Tulane Univ Med School    
      New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine    
      New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Univ of Pittsburgh Med School    
      Pittsburgh, Pennsylvania, United States
United States, Washington
Univ of Washington    
      Seattle, Washington, United States, 98105

Sponsors and Collaborators

Investigators
Study Chair:     Fischl M    
Study Chair:     Richman D    
Study Chair:     Murray H    
  More Information


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

Publications:
Henry K, Tierney C, Kahn J, Balfour H, Jiang Q, Kmack A, Fischl M. A randomized, double-blind, placebo-controlled study comparing combination nucleoside and triple therapy for the treatment of advanced HIV disease (CD4 less than or equal to 50/mm(3)). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:207 (abstract no LB6)
 
Skowron G, Bozzette SA, Lim L, Pettinelli CB, Schaumburg HH, Arezzo J, Fischl MA, Powderly WG, Gocke DJ, Richman DD, et al. Alternating and intermittent regimens of zidovudine and dideoxycytidine in patients with AIDS or AIDS-related complex. Ann Intern Med. 1993 Mar 1;118(5):321-30.
 

Study ID Numbers:   ACTG 112
First Received:   November 2, 1999
Last Updated:   August 7, 2008
ClinicalTrials.gov Identifier:   NCT00000682
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections  
Pneumonia, Pneumocystis carinii  
Zalcitabine  
Acquired Immunodeficiency Syndrome  
Zidovudine  

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Zalcitabine
Zidovudine
Immunologic Deficiency Syndromes
Virus Diseases
Pneumonia, Pneumocystis
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Retroviridae Infections
Pneumonia

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
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




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