Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada (ANRS134COPHAR3)
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| ClinicalTrials.gov Identifier: NCT00528060 |
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Recruitment Status
:
Completed
First Posted
: September 11, 2007
Last Update Posted
: December 22, 2011
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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
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Atazanavir Drug: Ritonavir Drug: Tenofovir/emtricitabine | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Intervention Details:
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Drug: Atazanavir
2pills/day
Drug: Ritonavir
1 pill/day
Drug: Tenofovir/emtricitabine
1 pill/day
Primary Outcome Measures
:
- pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine [ Time Frame: week 4 ]
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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
| First Posted: | September 11, 2007 Key Record Dates |
| Last Update Posted: | December 22, 2011 |
| Last Verified: | December 2011 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
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HIV infections atazanavir Pharmacokinetics Treatment Naive |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate Tenofovir Emtricitabine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |