Safety and clinical effects of IDX12899 in HIV-1 infection

ISRCTN	ISRCTN89417804
DOI	https://doi.org/10.1186/ISRCTN89417804
Protocol serial number	NV-05A-002
Sponsor	Idenix Pharmaceuticals (USA)
Funder	Idenix Pharmaceuticals (USA)

Submission date: 21/12/2007
Registration date: 06/02/2008
Last edited: 18/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Carlos Zala
Scientific

Hospital Privado Modelo
1811 Julio A Roca Street
Florida
B1602DBG
Partido de Vicente López
Buenos Aires
-
Argentina

Phone	+54 11 4792 7023
Email	clinicaltrials@idenix.com

Study information

Primary study design	Interventional
Study design	Phase I/IIa, randomized, double-blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	IDX12899 (antiretroviral drug)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	03/01/2008
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Argentina

Study participating centre

Hospital Privado Modelo

Buenos Aires
-
Argentina

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes