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HIV InfectionsPhase 2NCT00001066

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

A Phase 2 study testing Lamivudine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 months to 15 years
Conditions the study is for
HIV Infections
What is being tested?
Lamivudine, Zidovudine and Didanosine
How many people
740 participants
Where
91 sitesin 2 countries
Study dates
Start not givento Jan 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • IVIG.
  • Prophylaxis for opportunistic infection.
  • EPO.
  • G-CSF or GM-CSF.
Show all 16Show fewer
  • 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.

Who cannot join

  • 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:
Show all 18Show fewer
  • 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.

Trial locations and contacts

91 sites in 2 countries.

91 sites in 2 countries

United States87 sites

  • Children's Hosp at Albany Med Ctr

    Albany, New York, 12208

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Med College of Georgia

    Augusta, Georgia, 30912

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics

    Birmingham, Alabama, 35294

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Boston City Hosp / Pediatrics

    Boston, Massachusetts, 02118

  • King's County Hosp Ctr / Pediatrics

    Brooklyn, New York, 11203

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • Children's Hosp of Buffalo

    Buffalo, New York, 14222

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Mount Sinai Hosp Med Ctr

    Chicago, Illinois, 60608

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Univ of Chicago Children's Hosp

    Chicago, Illinois, 606371470

  • Cincinnati Children's Hosp / Univ Hosp

    Cincinnati, Ohio, 452292899

  • Case Western Reserve Univ - Pediatric

    Cleveland, Ohio, 44106

  • Univ of South Carolina School of Med

    Columbia, South Carolina, 29203

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Children's Med Ctr

    Dayton, Ohio, 454041518

  • Children's Hosp of Denver

    Denver, Colorado, 802181088

  • Children's Hosp of Michigan

    Detroit, Michigan, 48201

  • Duke Univ Med Ctr

    Durham, North Carolina, 277103499

  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Connecticut / Farmington

    Farmington, Connecticut, 06032

  • Children's Diagnostic and Treatment Ctr of South Florida

    Fort Lauderdale, Florida, 33301

  • Cook - Fort Worth Children's Med Ctr

    Fort Worth, Texas, 76104

  • Univ of Florida

    Gainesville, Florida, 32610

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Hermann Hosp / Univ Texas Health Science Ctr

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi, 392165405

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, 32209

  • UCSD Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, 920930672

  • Arkansas Children's Hosp

    Little Rock, Arkansas, 72202

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Children's Hosp of Los Angeles/UCLA Med Ctr

    Los Angeles, California, 900276016

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • Harbor - UCLA Med Ctr / UCLA School of Medicine

    Los Angeles, California, 905022004

  • Saint Jude Children's Research Hosp of Memphis

    Memphis, Tennessee, 381052794

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • Univ of Minnesota Med School

    Minneapolis, Minnesota, 55455

  • UMDNJ - Robert Wood Johnson Med School / Pediatrics

    New Brunswick, New Jersey, 089030019

  • Yale Univ Med School

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp

    New Hyde Park, New York, 11040

  • Tulane Univ / Charity Hosp of New Orleans

    New Orleans, Louisiana, 701122699

  • Beth Israel Med Ctr / Pediatrics

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Saint Luke's - Roosevelt Hosp Ctr

    New York, New York, 10025

  • Metropolitan Hosp Ctr

    New York, New York, 10029

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, 071032714

  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 07103

  • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 071072198

  • Senetara Norfolk Gen Hosp

    Norfolk, Virginia, 23507

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Arnold Palmer Hosp for Children & Women

    Orlando, Florida, 32806

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Rhode Island Hosp / Brown Univ

    Providence, Rhode Island, 02903

  • Virginia Commonwealth Univ

    Richmond, Virginia, 232980413

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California / Davis

    Sacramento, California, 958172208

  • Univ of Texas Health Science Ctr

    San Antonio, Texas, 78240

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Mem Children's Hosp

    Savannah, Georgia, 31404

  • Children's Hospital & Medical Center / Seattle ACTU

    Seattle, Washington, 981050371

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • St Louis Children's Hosp

    St Louis, Missouri, 63110

  • All Children's Hosp

    St. Petersburg, Florida, 33701

  • Stanford Univ School of Medicine

    Stanford, California, 943054149

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • SUNY Health Sciences Ctr at Syracuse / Pediatrics

    Syracuse, New York, 13210

  • Univ of South Florida

    Tampa, Florida, 33606

  • Saint Joseph's Hosp

    Tampa, Florida, 33614

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Westchester Hosp

    Valhalla, New York, 10595

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

  • HRS Palm Beach County Public Health Unit

    West Palm Beach, Florida, 33407

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, 016550001

Other trials in United States

Puerto Rico4 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Mayaguez Med Ctr

    Mayagüez, 00680

  • Univ of Puerto Rico / Univ Children's Hosp AIDS

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

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

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.

Read the detailed 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.

Conditions
HIV Infections
Being tested
Lamivudine, Zidovudine, Didanosine
Keywords
Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Lamivudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Primary completionJan 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
Double blind
Enrolment
740 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001066
Sponsor's protocol ID
ACTG 300
Status last verified
Mar 2011
First submitted
2 Nov 1999
Last updated
2 Mar 2011
Results posted
No

Publications

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

    PubMed 11364606

  • 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.

    PubMed 11364462

  • 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.

    PubMed 21037891

  • 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. doi: 10.1097/00002030-200311070-00007.

    PubMed 14571184

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lamivudine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001066, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.

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