Safety and clinical effects of IDX12899 in HIV-1 infection
| ISRCTN | ISRCTN89417804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89417804 |
| Secondary identifying numbers | NV-05A-002 |
- 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
Scientific
Hospital Privado Modelo
1811 Julio A Roca Street
Florida
B1602DBG
Partido de Vicente López
Buenos Aires
-
Argentina
| Phone | +54 11 4792 7023 |
|---|---|
| clinicaltrials@idenix.com |
Study information
| Study design | Phase I/IIa, randomized, double-blind, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | IDX12899 (antiretroviral drug) |
| Primary outcome measure | 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 study start date | 03/01/2008 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Target number of participants as of 27/06/2008: 40; Previous target number of participants: 10 |
| 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
-
Argentina
Sponsor information
Idenix Pharmaceuticals (USA)
Industry
Industry
One Kendall Square
Building 1400
Cambridge
02139
United States of America
| Phone | +1 617 995 9800 |
|---|---|
| clinicaltrials@idenix.com | |
| Website | http://www.idenix.com |
"ROR" |
https://ror.org/02891sr49 |
Funders
Funder type
Industry
Idenix Pharmaceuticals (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
