Safety and clinical effects of IDX12899 in HIV-1 infectio

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Male or Female, 21 to 65 years of age
2. Female of non-childbearing potential
3. Plasma HIV-1 RNA value >=5000 copies/mL
4. CD4+ count >=200 cells/mm3
5. Subject is antiretroviral treatment-naïve
6. Subject agrees to start a standard HAART regimen on Day 8 of the study or Kaletra® monotherapy for 28 days within 24 hours after the last dose of study medication
7. Subject has provided written informed consent to participate in the study

Exclusion Criteria

1. Pregnant or breastfeeding
2. Male of reproductive potential and unwilling to use double barrier method of contraception during and for at least 30 days after the last dose of the study drug
3. Co-infection with acute hepatitis A (HAV), chronic hepatitis B (HBV) or active hepatitis C (HCV)
4. Alcohol or illicit drug abuse, or history of alcohol abuse or illicit drug abuse within the preceding one year
5. Potential allergy to the study medication or the follow-up HAART or Kaletra® therapy
6. Received an immunomodulating agent or immunotherapeutic vaccine within 30 days before Day -1
7. Receiving co-medication that is a known substrate, inhibitor and/or inducer of CYP3A4
8. Enrollment in another clinical study of an investigational agent
9. Subject who has received any investigational drug within 90 days prior to Day -1
10. History of AIDS-defining illness
11. History of or currently active disease that may put the subject at risk because of participation in this study
12. Subject with an intestinal malabsorption
13. Subject with a pre-existing Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) drug resistance based on genotyping at Screening
14. Subject who has had a significant blood loss 30 days prior to Day -1
15. Subject has any of the following laboratory parameters at Screening: hemoglobin <8.5 g/dL, neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, serum creatinine > the Upper Limit of Normal (ULN), ASpartate aminoTransferase (AST) or ALanine aminoTransferase (ALT) >=2.5 x ULN, Total bilirubin >

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of subjects experiencing adverse events and laboratory abnormalities, followed-up until Study day 14 (7 days after the last dose of study drug) <br>2. Decrease from baseline through Day 8 in plasma HIV-1 RNA

Secondary Outcome Measures

Name	Time	Method
1. Change from baseline at Day 8 in Reverse Transcriptase (RT) sequences of HIV-1 <br>2. Change from baseline at Day 8 in CD4+ and CD8+ T-lymphocyte cell count <br>3. Plasma concentrations and calculated PharmacoKinetic (PK)/PharmacoDynamic (PD) parameters. The last PK sample is collected on Day 8 (24 hours after the last dose of study drug)<br>4. Profiling of metabolites. The last PK sample is collected on Day 8 (24 hours after the last dose of study drug)