A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Condition(s) targeted: HIV Infections

Intervention: Ritonavir (Drug); Nelfinavir mesylate (Drug); Nevirapine (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug); Zalcitabine (Drug); Didanosine (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Andrea Kovacs, Study Chair
Sandra Burchett, Study Chair

The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment.

Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

Official title: RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience

Study design: Treatment, Pharmacokinetics Study

Detailed description: The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.

In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV.

Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Minimum age: 6 Months. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

Your child may be eligible for this study if he or she:

- Is HIV-positive.

- Is between the ages of 6 months and 21 years (consent of parent or guardian required

if under 18).

- Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking

anti-HIV therapy.

- Has advanced HIV disease or disease progression while receiving 8 weeks or more of

continuous unchanged anti-HIV therapy.

- Is able to receive at least one of the following: RTV, NVP, or NFV.

Exclusion Criteria

Your child will not be eligible for this study if he or she:

- Is receiving treatment for a serious bacterial, viral, or opportunistic

(HIV-associated) infection within 14 days prior to study entry.

- Has a history of pancreatitis or peripheral neuropathy.

- Has cancer requiring chemotherapy.

- Is allergic to the study medications.

- Is taking certain medications.

- Is pregnant.

San Juan City Hosp, San Juan 009367344, Puerto Rico

Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico

Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon 00956, Puerto Rico

Univ of South Alabama, Mobile, Alabama 36604, United States

Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama 35233, United States

UCSF / Moffitt Hosp - Pediatric, San Francisco, California 941430105, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States

Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States

Children's Hosp of Oakland, Oakland, California 946091809, United States

Cedars Sinai / UCLA Med Ctr, Los Angeles, California 900481804, United States

Long Beach Memorial (Pediatric), Long Beach, California 90801, United States

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

Children's Hosp of Denver, Denver, Colorado 802181088, United States

Yale Univ Med School, New Haven, Connecticut 06504, United States

Connecticut Children's Med Ctr, Farmington, Connecticut 060303805, United States

Howard Univ Hosp, Washington, District of Columbia 20060, United States

Univ of Miami (Pediatric), Miami, Florida 33161, United States

Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States

North Broward Hosp District, Fort Lauderdale, Florida 33311, United States

Emory Univ Hosp / Pediatrics, Atlanta, Georgia 30306, United States

Med College of Georgia, Augusta, Georgia 30912, United States

The Med Ctr Inc, Columbus, Georgia 31901, United States

Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois 60612, United States

Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States

Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland 21201, United States

Johns Hopkins Hosp - Pediatric, Baltimore, Maryland 212874933, United States

Children's Hosp of Boston, Boston, Massachusetts 021155724, United States

Boston City Hosp / Pediatrics, Boston, Massachusetts 02118, United States

Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States

Univ of Massachusetts Med School, Worcester, Massachusetts 016550001, United States

Univ of Mississippi Med Ctr, Jackson, Mississippi 39213, United States

Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States

UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey 089030019, United States

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey 07103, United States

Harlem Hosp Ctr, New York, New York 10037, United States

SUNY - Brooklyn, Brooklyn, New York 11203, United States

Cornell Univ Med College, New York, New York 10021, United States

North Shore Univ Hosp, Great Neck, New York 11021, United States

Schneider Children's Hosp, New Hyde Park, New York 11040, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Columbia Presbyterian Med Ctr, New York, New York 10032, United States

Metropolitan Hosp Ctr, New York, New York 10029, United States

Children's Hosp at Albany Med Ctr, Albany, New York 12208, United States

SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States

State Univ of New York at Stony Brook, Stony Brook, New York 117948111, United States

Univ of Rochester Med Ctr, Rochester, New York 146420001, United States

Duke Univ Med Ctr, Durham, North Carolina 277103499, United States

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham, North Carolina 27710, United States

Columbus Children's Hosp, Columbus, Ohio 432052696, United States

Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 191044318, United States

Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania 191341095, United States

Med Univ of South Carolina, Charleston, South Carolina 294253312, United States

Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States

Vanderbilt Univ Med Ctr, Nashville, Tennessee 372322581, United States

Children's Med Ctr of Dallas, Dallas, Texas 75235, United States

Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States

Children's Hosp of the King's Daughters, Norfolk, Virginia 23507, United States

Med College of Virginia, Richmond, Virginia 23219, United States

Click here for more information about Zidovudine

Click here for more information about Zalcitabine

Click here for more information about Didanosine

Click here for more information about Stavudine

Click here for more information about Nevirapine

Click here for more information about Lamivudine

Click here for more information about Ritonavir

Click here for more information about Nelfinavir mesylate

Haga clic aquí para ver información sobre este ensayo clínico en español.

Related publications:

Weinberg A, Kovacs A, Pahwa S, Carey V, Oyomopito R, Mofenson L, Khoury M, Zimmer B, Burchett S. HIV-infected children on HAART reconstitute tetanus-specific T cell responses without booster vaccination. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 688)

Frenkel LM, Burchett SK, Aldrovandi GM, Carey V, Oyomopito R, Mahalanibis M, Decker D, Kovacs A. HIV-1 reverse transcriptase (RT) M184V/I improves the rate of suppression of viral replication by salvage therapy. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 463)

Kovacs A, Burchett S, Khoury M, Carey V, Pahwa S, McIntosh K, Oyomopito R, Smith E, Mofenson L. Virologic and immunologic responses in children with advanced HIV disease on a new HAART regimen (PACTG 366). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 684)

Last updated: June 23, 2005