Trial record 17 of 33 for:
" August 22, 2007":" September 21, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada (ANRS134COPHAR3)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00528060
First received: September 10, 2007
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Ritonavir Drug: Tenofovir/emtricitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
U.S. FDA Resources
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pharmacokinetics of emtricitabine and tenofovir; intraindividual variability in ARVs concentrations; adherence measured with MEMS records and validated ANRS observance autoquestionnaire; relationships between virological response or side event occurrence [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Atazanavir
2pills/day
Drug: Ritonavir
1 pill/day
Drug: Tenofovir/emtricitabine
1 pill/day
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Naïve of treatment HIV -1 infected patients
- CD4 above 100/mm3
Exclusion Criteria:
- pregnancy
- renal failure
- hepatitic disease
- ongoing opportunistic disease
- Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph > 2.5 N
- drugs interacting with investigational drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528060
Locations
| France | |
| Hopital du Kremlin Bicêtre Service de médecine interne | |
| Kremlin Bicëtre, France, 94275 | |
| Hopital Bichat CIC | |
| Paris cedex 18, France, 75877 | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb
Gilead Sciences
Investigators
| Principal Investigator: | Cécile Goujard, MD | AP-HP Kremlin-Bicetre |
| Study Director: | France Mentre, PHD | AP-HP Bichat, Inserm U738 |
More Information
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00528060 History of Changes |
| Other Study ID Numbers: | 2007-003203-12 |
| Study First Received: | September 10, 2007 |
| Last Updated: | December 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infections atazanavir Pharmacokinetics Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Atazanavir Tenofovir |
Tenofovir disoproxil Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013