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AzTrials

HIV InfectionsPhase 1NCT00000978

A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)

A Phase 1 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Zalcitabine
How many people
68 participants
Where
2 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • Pyrimethamine.
  • Triple sulfa.
  • Ansamycin.
  • Prolonged continuous use of high-dose nonsteroidal antiinflammatory agents.
  • Acetaminophen.
  • Amphotericin.
  • Foscarnet.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy if unlikely to cause peripheral neuropathy if their use is anticipated for treatment of acute intercurrent illness or opportunistic infection.
  • Transfusion for anemia.

Who cannot join

  • 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.
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  • 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.
  • Excluded within 4 weeks of study entry:
  • Drugs that have caused significant nephrotoxicity or significant hepatotoxicity (as defined by transaminases).
  • Concurrent Treatment:
  • Excluded:
  • Transfusion dependent.
  • Patients are excluded if unwilling or unable to sign informed consent.
  • Prior Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Dideoxycytidine (ddC).
  • Any other nucleoside antiretrovirals.
  • Positive antibody to HIV using any federally licensed ELISA test kit. Diagnosis of AIDS or AIDS-related complex (ARC).
  • Active substance or alcohol abuse.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Dose-Finding, Multicenter Trial of Dideoxycytidine (ddC) Administered Concurrently With Zidovudine (AZT) in the Treatment of AIDS or Advanced ARC

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.

Read the detailed description

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.

Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC. Patients are evaluated every week for the first 10 weeks and biweekly thereafter.

Conditions
HIV Infections
Being tested
Zidovudine, Zalcitabine
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
68 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000978
Sponsor's protocol ID
ACTG 106
Other IDs
Protocol N3447
Status last verified
Aug 1992
First submitted
2 Nov 1999
Last updated
8 Aug 2008
Results posted
No

Publications

  • 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.

    PubMed 1345755

  • 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)

  • 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.

    PubMed 2159707

  • 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.

    PubMed 9024175

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000978, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.

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