The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)
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Purpose
Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV) is an important component of combination ART in treatment naive individuals. Like many drugs, there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1 study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples collected over a 24-hour dosing interval in participants receiving either standard 600 mg or reduced 400 mg dose EFV once daily.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Efavirenz |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening |
| Official Title: | The Intensive Pharmacokinetics Sub-study of Encore1: A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks |
- To compare the pharmacokinetic parameters of EFV determined from blood collected over a 24-hour dosing interval in blinded samples from participants taking either 600 mg or 400 mg once daily in combination with Truvada. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- To investigate the correlation between EFV concentration measurements from dried blood spots and concentration measured in matched plasma samples. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Reduced dose Efavirenz arm
Participants randomized in main study to receive EFV (400 mg once daily; 2 x 200 mg + 1 x placebo once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily
|
Drug: Efavirenz
400 mg once daily; given as 2 x 200 mg + 1 x placebo
|
|
Active Comparator: Normal Efavirenz dose arm
Patients randomized in the main study to receive EFV (600 mg once daily; 3 x 200 mg once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily
|
Drug: Efavirenz
600 mg once daily; given as 3 x 200 mg once
|
Detailed Description:
This sub-study will investigate the relationships between dosage, EFV plasma concentrations, toxicity and virological efficacy. EFV concentrations in dried blood spots and matched plasma and will be evaluated to determine the utility of dried blood spot measurements in measuring EFV plasma concentrations. Measurements dried blood spots could potentially be a cheap and easy alternative to measurements in plasma. Dried blood spots can be easily collected from venous blood or fingerprick, do not need plasma separation and potentially need less stringent storage conditions during shipment.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
All participants enrolled into the main Encore1 study at participating sub-study sites will be eligible to participate.
Participants must meet the following additional inclusion criteria prior to intensive pharmacokinetic assessment. Inclusion Criteria:
- provide written sub-study consent at or before week 0
- taken randomized study drugs for at least 4 weeks but less than 8 weeks
- taken EFV in the evening for at least 7 days
- taken all EFV doses over the 3 preceding days.
Contacts and Locations| Argentina | |
| Hospital J.M. Ramos Mejia | |
| Buenos Aires, Argentina | |
| South Africa | |
| Desmond Tutu HIV Foundation | |
| Cape Town, South Africa | |
| Thailand | |
| Thai Red Cross-AIDS Research Centre, HIV-NAT Research Collaboration | |
| Bangkok, Thailand | |
| United Kingdom | |
| Chelsea and Westminister Hospital | |
| London, United Kingdom | |
| Principal Investigator: | Marta Boffito, Dr. | Chelsea & Westminster Hospital |
More Information
No publications provided
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT01271894 History of Changes |
| Other Study ID Numbers: | NCHECR-ENCORE1-PK |
| Study First Received: | January 5, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Kirby Institute:
|
HIV efavirenz pharmacokinetic |
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 |
Reverse Transcriptase Inhibitors Efavirenz Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 22, 2013