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

This study has been completed.

Sponsor:

Collaborators:

Bristol-Myers Squibb

Glaxo Wellcome

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00001066

First received: November 2, 1999

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

March 1, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

January 2001 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00001066 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Lamivudine
Drug: Zidovudine
Drug: Didanosine

Study Arm (s)

Not Provided

Publications *

[No authors listed] Combination therapies improve outlook for children with HIV disease. NIAID AIDS Agenda. 1997 Aug;:10. No abstract available.
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
James JS. Major pediatric study stopped early: combination treatment better. AIDS Treat News. 1997 Jul 4;(No 274):5-6. No abstract available.
Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.
Benjamin Jr DK, 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):2331-2336.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

740

Completion Date

Not Provided

Primary Completion Date

January 2001 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Months to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT Number ^ICMJE

NCT00001066

Other Study ID Numbers ^ICMJE

ACTG 300

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Bristol-Myers Squibb
Glaxo Wellcome

Investigators ^ICMJE

Study Chair:	McKinney RE
Study Chair:	Johnson GM

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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