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| Sponsor: | The University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00959894 |
Purpose
The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Etravirine (Intelence) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Etravirine 400 mg once daily: Experimental
Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
|
Drug: Etravirine (Intelence)
Etravirine 400 mg (four 100 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
|
Participants: There will be approximately 80 HIV-1-infected men and women aged 18 years or older who have taken less than or equal to 10 days of prior antiretroviral therapy and have never taken etravirine, dapivirine (TMC120), or rilpivirine (TMC 278) in the main study. There will be approximately 40 subjects who enroll in the main study that will be in the metabolic sub-study and approximately 20 subjects (10 pre-menopausal women and 10 men) who enroll in the main study that will be in the genital secretions PK sub-study.
Procedures (methods): For the main study subjects will take etravirine 400 mg once daily orally with fixed-dose tenofovir/emtricitabine (Truvada) one tablet once daily. For the genital secretions PK sub-study, genital secretion samples will be self-collected throughout the study except for the week 4 study visit where women will have the cervicovaginal sample at time 0 and at 24 hours collected by study staff. For the metabolic sub-study, waist measurements and DEXA scans will be performed at entry, week 24, and week 96, and 2-3 teaspoons of blood to check lipids, insulin, and glucose will be taken at entry and weeks 12, 24, 48, and 96.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For all women of reproductive potential, a negative urine or serum β-HCG pregnancy test performed within 48 hours prior to study entry.
NOTE: Acceptable documentation of lack of reproductive potential for a woman is self-reported history of being postmenopausal for at least 24 months, or having had surgical sterilization (hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation) or of male partner's azoospermia. Acceptable documentation for a man is self-reported history of azoospermia.
Exclusion Criteria:
Evidence of any of the resistance-associated mutations listed below at baseline on genotype testing performed at the study screening visit. Any pending resistance testing ordered prior to study entry must be available for review by the investigator prior to enrollment. Major resistance mutations include:
NOTE: Routine standard of care, including hepatitis B, influenza, pneumococcus, and tetanus vaccines are permitted.
Contacts and Locations| Contact: Tracey Lee, FNP | 919-843-8760 | tracey_lee@med.unc.edu |
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7215 | |
| Contact: Tracey Lee, FNP 919-843-8760 tracey_lee@med.unc.edu | |
| Principal Investigator: Michelle Floris-Moore, MD, MS | |
| Sub-Investigator: Joseph Eron, MD | |
| Sub-Investigator: David Wohl, MD | |
| Sub-Investigator: Kristine Patterson, MD | |
| Sub-Investigator: Angela Kashuba, PharmD | |
| Principal Investigator: | Michelle Floris-Moore, MD, MS | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | The University of North Carolina at Chapel Hill ( Michelle Floris-Moore, MD, MS ) |
| Study ID Numbers: | CID 0808, IND 104,941 |
| Study First Received: | August 14, 2009 |
| Last Updated: | December 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00959894 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Infection Treatment Naive Adults |
Once Daily Etravirine HIV-1 Infection |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Emtricitabine HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |