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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Ritonavir  Drug: Nelfinavir mesylate  Drug: Nevirapine  Drug: Lamivudine  Drug: Stavudine  Drug: Zidovudine  Drug: Zalcitabine  Drug: Didanosine	Phase I

Further Study Details: 

Expected Total Enrollment:  200

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.

Ages Eligible for Study:  6 Months   -   21 Years,  Genders Eligible for Study:  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.

Alabama
      Univ of South Alabama, Mobile,  Alabama,  36604,  United States
      Univ of Alabama at Birmingham - Pediatric, Birmingham,  Alabama,  35233,  United States
California
      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
Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States
Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06504,  United States
      Connecticut Children's Med Ctr, Farmington,  Connecticut,  060303805,  United States
District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States
Florida
      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
Georgia
      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
Illinois
      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
Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States
Massachusetts
      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
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  39213,  United States
New Jersey
      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
New York
      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
North Carolina
      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
Ohio
      Columbus Children's Hosp, Columbus,  Ohio,  432052696,  United States
Pennsylvania
      Children's Hosp of Philadelphia, Philadelphia,  Pennsylvania,  191044318,  United States
      Saint Christopher's Hosp for Children, Philadelphia,  Pennsylvania,  191341095,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States
Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  372322581,  United States
Texas
      Children's Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States
Virginia
      Children's Hosp of the King's Daughters, Norfolk,  Virginia,  23507,  United States
      Med College of Virginia, Richmond,  Virginia,  23219,  United States
Puerto Rico
      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

Study chairs or principal investigators

Andrea Kovacs,  Study Chair
Sandra Burchett,  Study Chair

Study ID Numbers:  ACTG 366
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000902
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08