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

Study ID Numbers:  NN210005
Record last reviewed:  August 2004
Record first received:  August 24, 2004
ClinicalTrials.gov Identifier:  NCT00090077
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10