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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.
Study NCT00000704.   Last updated on July 11, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
Official Title  A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
Brief Summary

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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Zalcitabine
MEDLINE PMIDs 2536257,   2159703
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  64
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000704
Organization ID ACTG 012
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     Merigan TC        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 1991
First Received Date  November 2, 1999
Last Updated Date July 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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