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 |
Recruitment Status
:
Completed
First Posted
: September 11, 2007
Last Update Posted
: December 22, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir Drug: Ritonavir Drug: Tenofovir/emtricitabine | Phase 2 |
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 |

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Drug: Atazanavir
- pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine [ Time Frame: week 4 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
Hopital du Kremlin Bicêtre Service de médecine interne | |
Kremlin Bicëtre, France, 94275 | |
Hopital Bichat CIC | |
Paris cedex 18, France, 75877 |
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:
HIV infections atazanavir Pharmacokinetics Treatment Naive |
Additional relevant MeSH terms:
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 |