This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Investigational HIV drugs	Phase II

Ages Eligible for Study:  2 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: - (All of these criteria must be met in order to be eligible to participate in this study)

• Females of child-bearing potential must have a negative pregnancy test at screening and on Day 1 and must agree to use a proven barrier method of contraception (e.g., spermicide plus condom). Note: hormonal contraceptives (e.g., birth control pills, Norplant, etc.) are not considered a sufficient form of contraception for this study.
• Parent or legal guardian (and study patient if possible) has the ability to understand what is required of the patient in the study, what will occur during the study, and provide written informed consent to participate.
• Screening lab result of plasma HIV-1 RNA greater than or equal to 400 copies/mL.
• Must be able to use 2 nucleoside reverse transcriptase inhibitors as a background regimen.

- Exclusion Criteria:

• No prior history of having received AGENERASE.
• No use of non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days of study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
• Cannot have had an AIDS defining illness (acute CDC Category C event) within 28 days of screening.
• Cannot be pregnant or breast-feeding.
• Additional qualifying criteria to be determined by the physician.

Alabama
      Birmingham,  Alabama,  35233,  United States
California
      Los Angeles,  California,  90027,  United States
      Los Angeles,  California,  90033,  United States
Florida
      Jacksonville,  Florida,  32209,  United States
      St. Petersburg,  Florida,  33701,  United States
Illinois
      Chicago,  Illinois,  60614,  United States
Louisiana
      New Orleans,  Louisiana,  70112,  United States
Massachusetts
      Boston,  Massachusetts,  02118,  United States
New York
      New York,  New York,  10016,  United States
      New York,  New York,  10021,  United States
      New York,  New York,  10029,  United States
      Bronx,  New York,  10461,  United States
      Stony Brook,  New York,  11794,  United States
      Syracuse,  New York,  13120,  United States
North Carolina
      Chapel Hill,  North Carolina,  27599,  United States
      Durham,  North Carolina,  27705,  United States
Ohio
      Cleveland,  Ohio,  44106,  United States
Texas
      Dallas,  Texas,  75235,  United States
      Fort Worth,  Texas,  76104,  United States
Virginia
      Richmond,  Virginia,  23219,  United States
Canada, Ontario
      Toronto,  Ontario,  M5G 1X8,  Canada
Canada, Quebec
      Montreal,  Quebec,  H3T 1C5,  Canada
Italy
      Rome,  00165,  Italy
      Genoa,  16147,  Italy
      Milan,  20122,  Italy
      Milan,  20142,  Italy
      Pavia,  27100,  Italy
      Padua,  35128,  Italy
      Verona,  37126,  Italy
      Modena,  41100,  Italy
      Florence,  50132,  Italy
Netherlands
      Rotterdam,  3015 GJ,  Netherlands
Portugal
      Lisbon,  1150,  Portugal
      Lisboa,  1649-035,  Portugal
      Amadora,  2700-276,  Portugal
Romania
      Bucharest,  Romania
      Bucharest,  Romania
      Bucharest,  Romania
Spain
      Barcelona,  08035,  Spain
      Barcelona,  08950,  Spain
      Cordoba,  14004,  Spain
      Madrid,  28007,  Spain
      Madrid,  28041,  Spain
      Madrid,  28046,  Spain
      Malaga,  29010,  Spain
      Seville,  410113,  Spain
United Kingdom
      London,  SW17 0QT,  United Kingdom
      London,  W2 1NY,  United Kingdom
      London,  WC1N 1EH,  United Kingdom

Study ID Numbers:  APV 20003
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2002
ClinicalTrials.gov Identifier:  NCT00040664
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08