A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

NCT00001005 | Completed Phase 1

• 2 other identifiers: ACTG 04211017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological responses which parallel those observed with IV dosing. Original design: To evaluate the short-term effects of combined administration of zidovudine (AZT) and increasing doses of recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get into the blood and how long they remain there (pharmacokinetics) will also be studied at each dose as well as the effect on HIV. Since AZT has no effect on cells that contain inactive virus (latently infected cells) and these cells may act as viral reservoirs, that a second agent that can destroy these infected cells would be useful in combination with AZT. The different activities of AZT and IL-2, as well as the non-overlapping nature of their mechanisms of action and toxicity, increase the theoretical benefits of combining AZT, a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of latently infected cells.

Conditions

HIV Infections

Keywords

Recombinant Proteins; HIV Seropositivity; Interleukin-2; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Zidovudine DRUG

Aldesleukin 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:
• Necessary topical agents, including nystatin or clotrimazole, as well as acyclovir. Patients on medications without which the patient would be placed at significant risk (seizures, diabetic control, respiratory embarrassment) may continue only at the discretion of the study pharmacologist.
• Patients must have:
• Asymptomatic HIV infection associated with lymphadenopathy.
• Walter Reed Stage II disease, with positive antibody to HIV confirmed by Western blot test.

You may not qualify if:

• Co-existing Condition:
• Patients will be excluded from the study for the following:
• Development of a disease requiring a drug which might potentiate toxicity of the study drugs or a drug likely to have antiretroviral effect.
• Active opportunistic infection.
• Major organ allograft.
• Significant cardiac or pulmonary disease or central nervous system (CNS) lesions.
• Concurrent Medication:
• Excluded:
• Ongoing therapy for an opportunistic infection.
• Beta-blockers.
• Antihypertensive medication other than diuretics.
• All nonessential medication including pain medications.
• Patients without interleukin 2 (IL-2) augmentable anti-HIV antibody-dependent cellular cytotoxicity (ADCC) or or cell-mediated cytotoxicity (CMC) in vitro are excluded.
• Prior Medication:
• Excluded within 12 weeks of study entry:

Sponsors & Collaborators

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

Study Sites (1)

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Weinhold K, Tyler D, Austin A, Lyerly K, Bolognesi D, Bartlett J. Augmentation of non-mhc restricted cellular cytotoxicities in patients receiving Zidovudine plus interleukin 2. Int Conf AIDS. 1989 Jun 4-9;5:406 (abstract no WBP330)

  BACKGROUND

• Bartlett JA, Blankenship KD, Greenberg M, Tyler DS, Weinhold KJ. The safety of Zidovudine and interleukin 2 in asymptomatic HIV infected patients. Int Conf AIDS. 1989 Jun 4-9;5:406 (abstract no WBP325)

  BACKGROUND

• Bartlett JA, Berend C, Petroni GR, Ottinger J, Tyler DL, Pettinelli C, Weinhold KJ. Coadministration of zidovudine and interleukin-2 increases absolute CD4 cells in subjects with Walter Reed stage 2 human immunodeficiency virus infection: results of ACTG protocol 042. J Infect Dis. 1998 Oct;178(4):1170-3. doi: 10.1086/515677.

  PMID: 9806053 BACKGROUND

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine; aldesleukin

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)

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

Study Officials

• K Weinhold

  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: February 1, 1995
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)