This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.

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

Ages Eligible for Study:  up to  2 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or females 4 weeks to < 2 years of age
• Parent or legal guardian has the ability to understand and provide written informed consent.
• Screening plasma HIV-1 RNA > or = 400 copies/mL.
• Must be able to construct an active 2 NRTI (nucleoside reverse transcriptase inhibitor) backbone regimen.

Exclusion Criteria:

• Prior history of having received the drug AGENERASE.
• Non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days prior to study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
• PI (protease inhibitor) therapy within 5 days prior to study drug administration
• Have not had an AIDS defining illness (acute CDC Category C event) within 28 days of screen.
• Other inclusion or exclusion criteria to be determined by the physician.

Florida
      Jacksonville,  Florida,  32209,  United States; Recruiting
New York
      New York,  New York,  10016,  United States; Not yet recruiting
      Bronx,  New York,  10461,  United States; Terminated
      Syracuse,  New York,  13210,  United States; Terminated
North Carolina
      Durham,  North Carolina,  27705,  United States; Not yet recruiting
Argentina
      Buenos Aires,  1644,  Argentina; Not yet recruiting
Mexico
      Mexico,  06720,  Mexico; Recruiting
      Mexico Distrito Federal,  CP 06720,  Mexico; Recruiting
Panama
      Panama,  5-4807,  Panama; Not yet recruiting
Portugal
      Lisboa,  1649-035,  Portugal; Not yet recruiting
      Amadora,  2700-276,  Portugal; Recruiting
      Porto,  4200-319,  Portugal; Not yet recruiting
Puerto Rico
      San Juan,  00936,  Puerto Rico; Recruiting

Study ID Numbers:  APV20002
Record last reviewed:  February 2005
Last Updated:  February 3, 2005
Record first received:  October 30, 2003
ClinicalTrials.gov Identifier:  NCT00071760
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08