Contact information
Type
Scientific
Primary contact
Dr Carlos Zala
ORCID ID
Contact details
Hospital Privado Modelo
1811 Julio A Roca Street
Florida
B1602DBG
Partido de Vicente López
Buenos Aires
-
Argentina
+54 11 4792 7023
clinicaltrials@idenix.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NV-05A-002
Study information
Scientific title
A phase I/IIa, double-blind study to evaluate the safety and tolerability, antiretroviral activity, pharmacokinetics and pharmacodynamics of IDX12899 in antiretroviral treatment-naïve HIV-1-infected subjects
Acronym
Study hypothesis
The safety profile and antiviral activity demonstrated in vitro by IDX12899 predicts acceptable safety and antiviral activity in HIV-1-infected patients.
As of 27/06/2008, the anticipated end date of this trial has been updated. The previous anticipated end date was 28/02/2008.
Ethics approval
Independent Ethics Committee in Clinical Research c/o Dr Virgilio G. Foglia Registration OHRP No: IRB 00001678 - USA.
Tucumán 335 -7o piso "D" - (C1049AAG) Buenos Aires, Argentina) approval ref 653/65/2007.
Study design
Phase I/IIa, randomized, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic HIV-1 infection
Intervention
From 27/06/2008: Sequential cohorts of 10 subjects will be randomised at an 8:2 ratio to receive IDX12899 (oral capsule) 800 mg, 400 mg, 200 mg and 100 mg or placebo once daily for 7 days.
Before 27/06/2008: Subjects will be randomised at an 8:2 ratio to receive IDX12899 (oral capsule) 800 mg once daily or placebo for 7 days.
Intervention type
Drug
Phase
Phase I/II
Drug names
IDX12899 (antiretroviral drug)
Primary outcome measures
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)
2. Decrease from baseline through Day 8 in plasma HIV-1 RNA
Secondary outcome measures
1. Change from baseline at Day 8 in Reverse Transcriptase (RT) sequences of HIV-1
2. Change from baseline at Day 8 in CD4+ and CD8+ T-lymphocyte cell count
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)
4. Profiling of metabolites. The last PK sample is collected on Day 8 (24 hours after the last dose of study drug)
Overall trial start date
03/01/2008
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target number of participants as of 27/06/2008: 40; Previous target number of participants: 10
Participant 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 >ULN
Recruitment start date
03/01/2008
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Argentina
Trial participating centre
Hospital Privado Modelo
Buenos Aires
-
Argentina
Sponsor information
Organisation
Idenix Pharmaceuticals (USA)
Sponsor details
One Kendall Square
Building 1400
Cambridge
02139
United States of America
+1 617 995 9800
clinicaltrials@idenix.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Idenix Pharmaceuticals (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary