Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

NCT00000851 | Completed Phase 2

• 2 other identifiers: ACTG 32711300
• Study Type: interventional
• Target: 198
• Locations: 2 countries
• Sites: 35

Brief Summary

To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Antiviral Agents; Stavudine

Interventions

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must:
• Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
• Have laboratory evidence of HIV-1 infection \< 18 months - 2 positive viral tests \>= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
• Have parent or legal guardian willing to sign a consent.
• Prior Medication: Required:
• On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.

You may not qualify if:

• Co-existing Condition:
• Patients with any of the following symptoms or conditions are excluded:
• Intractable diarrhea or vomiting.
• Current clinical or laboratory Grade 3 or worse toxicities.
• Concurrent Medication:
• Excluded:
• Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
• Chemotherapy for active malignancy.
• Patients with any of the following prior conditions are excluded:
• Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
• Prescription AZT recipients may not have received \> 6 weeks of d4T or ddI previously.
• Subjects who have had chemotherapy for active malignancy.
• Prior Medication:
• Excluded:
• Prescription AZT recipients may not have received \> 6 weeks of d4T or ddI previously.

Sponsors & Collaborators

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

Study Sites (35)

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, 90502, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, United States

Location

Univ. of Connecticut Health Ctr., Dept. of Ped.

Farmington, Connecticut, 06032, United States

Location

Connecticut Children's Med. Ctr.

Hartford, Connecticut, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20010, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Cook County Hosp.

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, 60637, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, 21201, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, 08903, United States

Location

NJ Med. School CRS

Newark, New Jersey, United States

Location

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, 11203, United States

Location

North Shore-Long Island Jewish Health System, Dept. of Peds.

Great Neck, New York, 11021, United States

Location

Schneider Children's Hosp., Div. of Infectious Diseases

New Hyde Park, New York, 11040, United States

Location

Metropolitan Hosp. NICHD CRS

New York, New York, 10029, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

Charleston, South Carolina, 29425, United States

Location

Children's Med. Ctr. Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

Bayamón, 00956, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (2)

• Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, Diaz C, Yogev R, McKinney RE Jr, Abrams EJ, Mofenson LM. Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team. Pediatrics. 1999 May;103(5):e62. doi: 10.1542/peds.103.5.e62.

  PMID: 10224206 BACKGROUND

• Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

  PMID: 21037891 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Stavudine; 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)

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

Study Officials

• Kline M

  STUDY CHAIR

• Van Dyke R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (32); PR (3)