A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

HIV Infections Clinical Trial

Official title:

A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001066
• Other study ID #: ACTG 300
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: March 1, 2011

Study information

• Verified date: March 2011
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens.

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Description:

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 15 Years

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• IVIG.

• Prophylaxis for opportunistic infection.

• EPO.

• G-CSF or GM-CSF.

Patients must have:

• Symptomatic HIV infection.

• Less than 56 days of prior antiretroviral therapy.

• Consent of parent or guardian.

NOTE:

• Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.

Prior Medication:

Allowed:

• Up to 56 days of prior antiretroviral therapy.

• Prior immunomodulator therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malignancy.

• Hypersensitivity to a nucleoside analog.

• Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.

PER AMENDMENT 4/29/96:

• Active opportunistic infection and/or serious bacterial infection at the time of entry.

Concurrent Medication:

Excluded:

• Any other anti-HIV therapy.

• Megestrol acetate ( Megace ).

• Probenecid.

• IV pentamidine.

• Human growth hormone ( hGH ).

• Systemic corticosteroids for more than 2 weeks.

Prior Medication:

Excluded:

• Investigational drug therapy within 14 days prior to study entry.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine

• Zidovudine

• Didanosine

Locations

Country	Name	City	State
Puerto Rico	Ramon Ruiz Arnau Univ Hosp / Pediatrics	Bayamon
Puerto Rico	Mayaguez Med Ctr	Mayaguez
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	Med College of Georgia	Augusta	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	Boston City Hosp / Pediatrics	Boston	Massachusetts
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	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	Children's Hosp of Buffalo	Buffalo	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	Mount Sinai Hosp Med Ctr	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	Cincinnati Children's Hosp / Univ Hosp	Cincinnati	Ohio
United States	Case Western Reserve Univ - Pediatric	Cleveland	Ohio
United States	Univ of South Carolina School of Med	Columbia	South Carolina
United States	Columbus Children's Hosp	Columbus	Ohio
United States	Children's Med Ctr of Dallas	Dallas	Texas
United States	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	Children's Diagnostic and Treatment Ctr of South Florida	Fort Lauderdale	Florida
United States	Cook - Fort Worth Children's Med Ctr	Fort Worth	Texas
United States	Univ of Florida	Gainesville	Florida
United States	North Shore Univ Hosp	Great Neck	New York
United States	Hermann Hosp / Univ Texas Health Science Ctr	Houston	Texas
United States	Texas Children's Hosp / Baylor Univ	Houston	Texas
United States	Univ of Mississippi Med Ctr	Jackson	Mississippi
United States	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida
United States	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California
United States	Arkansas Children's Hosp	Little Rock	Arkansas
United States	Long Beach Memorial (Pediatric)	Long Beach	California
United States	Children's Hosp of Los Angeles/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	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Univ of Minnesota Med School	Minneapolis	Minnesota
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	Harlem Hosp Ctr	New York	New York
United States	Metropolitan Hosp Ctr	New York	New York
United States	Mount Sinai Med Ctr / Pediatrics	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl	Newark	New Jersey
United States	Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl	Newark	New Jersey
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	Senetara Norfolk Gen Hosp	Norfolk	Virginia
United States	Children's Hosp of Oakland	Oakland	California
United States	Arnold Palmer Hosp for Children & Women	Orlando	Florida
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	Virginia Commonwealth Univ	Richmond	Virginia
United States	Univ of Rochester Medical Center	Rochester	New York
United States	Univ of California / Davis	Sacramento	California
United States	Univ of Texas Health Science Ctr	San Antonio	Texas
United States	UCSF / Moffitt Hosp - Pediatric	San Francisco	California
United States	Mem Children's Hosp	Savannah	Georgia
United States	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington
United States	Baystate Med Ctr of Springfield	Springfield	Massachusetts
United States	St Louis Children's Hosp	St Louis	Missouri
United States	All Children's Hosp	St Petersburg	Florida
United States	Stanford Univ School of Medicine	Stanford	California
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	Saint Joseph's Hosp	Tampa	Florida
United States	Univ of South Florida	Tampa	Florida
United States	Westchester Hosp	Valhalla	New York
United States	Children's Hosp of Washington DC	Washington	District of Columbia
United States	Howard Univ Hosp	Washington	District of Columbia
United States	HRS Palm Beach County Public Health Unit	West Palm Beach	Florida
United States	Univ of Massachusetts Med School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Bristol-Myers Squibb, Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

Benjamin DK Jr, Miller WC, Benjamin DK, Ryder RW, Weber DJ, Walter E, McKinney RE. A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV. AIDS. 2003 Nov 7;17(16):2331-6. — View Citation

Combination therapies improve outlook for children with HIV disease. NIAID AIDS Agenda. 1997 Aug:10. — View Citation

James JS. Major pediatric study stopped early: combination treatment better. AIDS Treat News. 1997 Jul 4;(No 274):5-6. — View Citation

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

External Links

•   Click here for more information about Didanosine
•   Click here for more information about Lamivudine
•   Click here for more information about Zidovudine