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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

August 25, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Lamivudine
Drug: Zidovudine
Drug: Didanosine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

740

Completion Date

Primary Completion Date

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 ID ^ICMJE

NCT00001066

Responsible Party

Study ID Numbers ^ICMJE

ACTG 300

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

November 1998

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