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

NCT00000704 | Completed Phase 1

• 2 other identifiers: ACTG 01210988
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV Antigens; Immunologic Surveillance; Zalcitabine; Dose-Response Relationship, Drug; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; CD4-Positive T-Lymphocytes

Interventions

Zalcitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ. of Miami AIDS CRS

Miami, Florida, 331361013, United States

Location

Related Publications (2)

• Merigan TC, Skowron G, Bozzette SA, Richman D, Uttamchandani R, Fischl M, Schooley R, Hirsch M, Soo W, Pettinelli C, et al. Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study. Ann Intern Med. 1989 Feb 1;110(3):189-94. doi: 10.7326/0003-4819-110-3-189.

  PMID: 2536257 BACKGROUND

• Merigan TC, Skowron G. Safety and tolerance of dideoxycytidine as a single agent. Results of early-phase studies in patients with acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex. Study Group of the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. Am J Med. 1990 May 21;88(5B):11S-15S. doi: 10.1016/0002-9343(90)90415-a.

  PMID: 2159703 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zalcitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Merigan TC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)