Condition category
Infections and Infestations
Date applied
21/12/2007
Date assigned
06/02/2008
Last edited
18/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.idenix.com

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

Publication citations

Additional files

Editorial Notes