NCT00000978

Brief Summary

To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC). Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 1992

First QC Date

November 2, 1999

Last Update Submit

August 6, 2008

Conditions

HIV Infections

Keywords

ZalcitabineDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudine

Interventions

ZidovudineDRUG
ZalcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine 300 mg per 4 weeks.
  • Drugs unlikely to cause increased toxicity with either study drug and unlikely to cause peripheral neuropathy.
  • Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity, that patient has been taking and tolerating well for ongoing condition.
  • Acyclovir (= or \< 600 mg/day, orally).
  • Ketoconazole (= or \< 400 mg/day).
  • Nystatin (occasional).
  • Acetaminophen or nonsteroidal antiinflammatory agents (low dose).
  • Drugs that could possibly cause serious additive toxicity when coadministered with either study drug, but unlikely to cause peripheral are allowed only if their use is anticipated for treatment of acute intercurrent illness or opportunistic infections.
  • Allowed only with a study drug interruption of up to 21 days per episode, for a total of 42 days for the study:
  • Acyclovir (\> 600 mg/day).
  • Experimental drugs including ganciclovir.
  • Fluconazole.
  • Systemic pentamidine.
  • +11 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active opportunistic infections requiring treatment with unallowed drugs.
  • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within 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.
  • History of peripheral neuropathy or any significant signs or symptoms of neurological disease, or abnormality indicative of peripheral neuropathy.
  • Significant cardiac disease defined as history of ventricular arrhythmias requiring medication, prior myocardial infarction, or history of angina or ischemic changes on electrocardiogram.
  • Significant liver disease as defined by transaminase levels or by history of cirrhosis or ascites.
  • Significant renal disease defined by serum creatinine.
  • Concurrent Medication:
  • Excluded:
  • Experimental drugs including fluconazole, and foscarnet.
  • Immunomodulators including interferon, interleukins, or systemic corticosteroids.
  • Ganciclovir.
  • Neurotoxic drugs.
  • Drugs that could potentially cause peripheral neuropathy, including chloramphenicol, cisplatin, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, vincristine, and nitrofurantoin.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Related Publications (4)

  • Meng TC, Fischl MA, Boota AM, Spector SA, Bennett D, Bassiakos Y, Lai SH, Wright B, Richman DD. Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection. A phase I/II study. Ann Intern Med. 1992 Jan 1;116(1):13-20. doi: 10.7326/0003-4819-116-1-13.

    PMID: 1345755BACKGROUND

  • Meng TC, Boota A, Fischl MA, Spector SA, McCaan M, Richman DD. ACTG 106: Phase I/II dose finding study of concurrently administered dideoxycytidine (ddC) and zidovudine (ZDV, AZT). Int Conf AIDS. 1990 Jun 20-23;6(3):192 (abstract no SB426)

    BACKGROUND

  • Meng TC, Fischl MA, Richman DD. AIDS Clinical Trials Group: phase I/II study of combination 2',3'-dideoxycytidine and zidovudine in patients with acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related complex. Am J Med. 1990 May 21;88(5B):27S-30S. doi: 10.1016/0002-9343(90)90419-e.

    PMID: 2159707BACKGROUND

  • Gries JM, Troconiz IF, Verotta D, Jacobson M, Sheiner LB. A pooled analysis of CD4 response to zidovudine and zalcitabine treatment in patients with AIDS and AIDS-related complex. Clin Pharmacol Ther. 1997 Jan;61(1):70-82. doi: 10.1016/S0009-9236(97)90183-1.

    PMID: 9024175BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

ZidovudineZalcitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDeoxycytidineCytidine

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

August 8, 2008

Record last verified: 1992-08

Locations

US(2)