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NCT00000814 Clinical Trial

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

HIV Infections Clinical Trial

Official title:
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000814
Other study ID # ACTG 245
Secondary ID 11222
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date November 1998

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

Description:

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance. In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks. AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date November 1998
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Months to 20 Years
Eligibility Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin. Concurrent Treatment: Allowed: - Transfusion. Patients must have: - Progressive HIV disease. - At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active malignancy requiring chemotherapy. - Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study. - Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study. Concurrent Medication: Excluded (unless exemption made by study chair): - Oral anticoagulants (warfarin, dicumarol). - Oral contraceptives. - Digitalis glycosides. - Phenytoin. - Theophylline. Patients with the following prior conditions are excluded: - History of clinical pancreatitis. - History of grade 2 or worse peripheral neuropathy. Prior Treatment: Excluded: - Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nevirapine

• Zidovudine

• Didanosine

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham Schl of Med / Pediatrics Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr Bronx New York
United States King's County Hosp Ctr / Pediatrics Brooklyn New York
United States SUNY - Brooklyn Brooklyn New York
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Columbus Children's Hosp Columbus Ohio
United States Children's Med Ctr of Dallas Dallas Texas
United States West Central Ohio Hemophilia Ctr / Children's Med Ctr Dayton Ohio
United States Children's Hosp of Denver Denver Colorado
United States Children's Hosp of Michigan Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr Durham North Carolina
United States Univ of Connecticut / Farmington Farmington Connecticut
United States North Shore Univ Hosp Great Neck New York
United States Milton S Hershey Med Ctr Hershey Pennsylvania
United States Univ of Pittsburgh Med School / Hershey Med Ctr Hershey Pennsylvania
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States Long Beach Memorial (Pediatric) Long Beach California
United States Cedars Sinai / UCLA Med Ctr Los Angeles California
United States Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States Los Angeles County - USC Med Ctr Los Angeles California
United States UCLA Med Ctr / Pediatric Los Angeles California
United States Univ of Miami (Pediatric) Miami Florida
United States UMDNJ - Robert Wood Johnson Med School / Pediatrics New Brunswick New Jersey
United States Yale Univ Med School New Haven Connecticut
United States Schneider Children's Hosp New Hyde Park New York
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr / Pediatrics New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med College New York New York
United States Harlem Hosp Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York
United States Metropolitan Hosp Ctr New York New York
United States Mount Sinai Med Ctr / Hemophilia Treatment Ctr New York New York
United States Mount Sinai Med Ctr / Pediatrics New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Children's Hosp of the King's Daughters Norfolk Virginia
United States Children's Hosp of Oakland Oakland California
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Saint Christopher's Hosp for Children Philadelphia Pennsylvania
United States Rhode Island Hosp / Brown Univ Providence Rhode Island
United States Univ of Rochester Medical Center Rochester New York
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States State Univ of New York at Stony Brook Stony Brook New York
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York
United States Westchester Hosp Valhalla New York
United States Children's Hosp of Washington DC Washington District of Columbia
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (4)

Burchett S, Sullivan J, Luzuriaga K, Carey V, Yong F, Culnane M, Mofenson L, Robinson P. Combinations of didanosine (DDI), zidovudine (ZDV) and nevirapine (NVP) can reduce CSF HIV-1 viral load in pediatric patients with advanced HIV disease. Int Conf AIDS. 1998;12:62 (abstract no 12253)

Burchett SK, Carey V, Yong F, Sullivan J, Sulzbacher S, Civitello L, Culnane M, Mofenson L, Siminski S, Robinson P, Luzuriaga K. Virologic activity of didanosine (ddI), zidovudine (ZDV) and nevirapine (NVP) combinations in pediatric subjects with advanced HIV disease (ACTG 245). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:130 (abstract no 271)

McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

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. — View Citation

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