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A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
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: NCT00000704
  Purpose

To evaluate the long-term safety and effectiveness of the drug 2',3'-dideoxycytidine ( zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ).

Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS.


Condition Intervention Phase
HIV Infections
Drug: Zalcitabine
Phase I

MedlinePlus related topics: AIDS
Drug Information available for: Zalcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.

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

Estimated Enrollment: 64
Detailed Description:

Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS.

A range of doses of ddC is given to patients with AIDS and ARC. Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks. Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum (the fluid portion of the blood) are continued at that dose for an additional 12 weeks. Patients who do not respond at a given dose level (no rise in T4 or fall in serum HIV antigen) stop treatment at 12 weeks. All patients are followed off therapy for 4 weeks. As each dose level is found to be well tolerated for 10 weeks in five of the eight patients in each group, additional patients will be entered at higher dose levels until eight AIDS and eight ARC patients are receiving the drug at a given level.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents.
  • Acute therapy (7 days) with oral acyclovir.
  • Acute therapy with ketoconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Negative antigen test within 2 weeks of starting therapy.
  • Significant malabsorption (> 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml).
  • Significant cardiac, liver, or neurologic disease.
  • For group A:
  • Opportunistic infection or malignancy fulfilling definition of AIDS, or with concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • For group B:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or with concurrent neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix.

Concurrent Medication:

Excluded:

  • Acyclovir therapy.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Other antiretroviral agents, biologic modifiers, or systemic corticosteroids.
  • Other experimental medications, sedatives, and barbiturates.
  • Group B:
  • Therapy and/or prophylaxis for AIDS-defining opportunistic infection, antineoplastic therapy.

Concurrent Treatment:

Excluded:

- Transfusion dependency (requiring 2 units of blood more than once per month). Patients with history of idiopathic thrombocytopenia purpura are excluded.

Prior Medication:

Excluded within 30 days of study entry:

  • Biologic modifiers or corticosteroids.
  • Excluded within 90 days of study entry:
  • Antiretroviral agents.

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Transfusion.

Inclusion criteria are:

  • Consistently positive HIV antigen as defined by Abbott HIV antigen test. This demonstration will be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy.
  • HIV antigen titer must be = or > 100 pg.
  • Positive antibody to HIV confirmed by any federally licensed enzyme-linked immunosorbent assay (ELISA) test kit.

The following conditions are allowed:

- Basal cell carcinoma of the skin or in situ carcinoma of the cervix. Active substance abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000704

Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford Univ School of Medicine
Stanford, California, United States, 94305
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Investigators
Study Chair: Merigan TC
  More Information

Publications:
Study ID Numbers: ACTG 012
Study First Received: November 2, 1999
Last Updated: July 11, 2008
ClinicalTrials.gov Identifier: NCT00000704  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Antigens
Immunologic Surveillance
Zalcitabine
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
CD4-Positive T-Lymphocytes

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

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 January 15, 2009