To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Investigational HIV drug	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• CD4 cell count greater than or equal to 200 cells/mm3.
• HIV-1 RNA >2000 copies/mL.
• Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavradine.
• Normal resting 12-lead electrocardiogram

Exclusion criteria:

• Any history of seizure, CNS toxoplasmosis infection, or any CNS lesion.
• Chronic diarrhea (>3 loose stools/day).
• An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
• Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
• Any acute laboratory abnormality.
• Positive for HCV antibody or HepBsAG.
• Active infections requiring therapy in the previous 4 weeks.

Arizona
      Phoenix,  Arizona,  85006,  United States
California
      West Hollywood,  California,  90069,  United States
      Fountain Valley,  California,  92708,  United States
      San Francisco,  California,  94115,  United States
      San Francisco,  California,  94115,  United States
District of Columbia
      Washington,  District of Columbia,  20007,  United States
Florida
      Altamonte Springs,  Florida,  32701,  United States
      Vero Beach,  Florida,  32960,  United States
      Miami,  Florida,  33136,  United States
      Miami Beach,  Florida,  33140,  United States
      Fort Lauderdale,  Florida,  33308,  United States
Georgia
      Atlanta,  Georgia,  30308,  United States
Massachusetts
      Boston,  Massachusetts,  02215,  United States
Nevada
      Las Vegas,  Nevada,  89102,  United States
New York
      New York,  New York,  10008,  United States
North Carolina
      Charlotte,  North Carolina,  28209,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73104,  United States
Texas
      Fort Worth,  Texas,  76104,  United States
Washington
      Seattle,  Washington,  98104,  United States

Study ID Numbers:  NN210005
Record last reviewed:  February 2005
Last Updated:  February 28, 2005
Record first received:  August 24, 2004
ClinicalTrials.gov Identifier:  NCT00090077
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08