The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children

NCT00000865 | Completed Phase 1

• 2 other identifiers: ACTG 33011302
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

Brief Summary

To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Interventions

Abacavir sulfate DRUG

Lamivudine DRUG

Stavudine DRUG

Zidovudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 3 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Concurrent Medication:
• Allowed:
• IVIG.
• Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor (for management of hematologic toxicity).
• Patients must have:
• Documented HIV-1 infection.
• Laboratory evidence of immunosuppression or symptomatic HIV disease.
• Parent or legal guardian able and willing to provide signed informed consent.
• Prior Medication: Required:
• HIV infected infants and children will be eligible for the trial if they have received greater than 56 days of previous antiretroviral therapy.
• NOTE:

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Grade 3 or greater abnormalities in any toxicity monitoring laboratory tests at baseline.
• Presence of an acute opportunistic infection requiring therapy at the time of enrollment.
• Intractable or chronic diarrhea or vomiting.
• Concurrent Medication:
• Excluded:
• Chemotherapy for active malignancy.
• Concurrent use of antiretroviral agents other than those provided by the study, biologic response modifiers, human growth hormone, systemic corticosteroids (\>= 14 days duration), probenecid, I.V. pentamidine, immunomodulators (other than intravenous immunoglobulin), or other investigational drugs.
• Patients with any of the following prior conditions or symptoms are excluded:
• \- History of intolerance to any of the study drugs.

Sponsors & Collaborators

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

Study Sites (7)

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 920930672, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 701122699, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 277103499, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 381052794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hughes W, McDowell J, L Adams, Flynn P, Hetherington S, Kline M, Shenep J, Yogev R, Lafon S. Evaluation of the novel nucleoside 1592U89 in a phase I safety and pharmacokinetics (PK) study in HIV-infected infants and children. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:115

  BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; Lamivudine; Stavudine; Zidovudine; Didanosine

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

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Kline M

  STUDY CHAIR

• Van Dyke R

  STUDY CHAIR

• Yogev R

  STUDY CHAIR

• Shenep J

  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, 1998
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (7)