Status:
COMPLETED
Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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/emtricitabin...
Detailed Description
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 etrav...
Eligibility Criteria
Inclusion
- HIV-1 infection as documented by any licensed ELISA test and confirmed by Western Blot or other confirmatory test at any time prior to study entry. Acceptable alternative confirmatory tests are plasma HIV-1 RNA, HIV-1 culture, HIV-1 antigen, or a second antibody test by a method other than ELISA. Alternatively, if an HIV-antibody test result is not available, two HIV-1 RNA values \>2000 copies/mL, drawn at least 24 hours apart, performed by any laboratory that has clinical laboratory improvement amendments (CLIA) certification, or its equivalent, may be used to document infection.
- Age 18 years or older.
- Able to provide informed consent.
- In the opinion of the investigator, able to comply with study medication and procedures.
- Plasma HIV-1 RNA ≥ 1000 copies/mL as measured by any FDA-approved test for quantifying HIV-1 RNA within 90 days prior to study entry.
- Less than or equal to 10 days of cumulative exposure to antiretroviral therapy.
- For all women of reproductive potential, a negative urine or serum β-human chorionic gonadotropin (β-HCG) pregnancy test performed within 48 hours prior to study entry.
- All study volunteers, both male and female, must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) while receiving study medications and for 6 weeks after stopping study medications.
- If participating in sexual activity that could lead to conception, study volunteers must agree to use at least one method of reliable contraception which must be a barrier method (i.e., a condom without spermicide, a diaphragm, or cervical cap) throughout the study and for 6 weeks thereafter.
- 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.
- Hemoglobin ≥ 7.5 g/dL within 45 days prior to study entry.
- Absolute neutrophil count ≥ 500/mm³ within 45 days prior to study entry.
- Platelets ≥ 50,000/mm³ within 45 days prior to study entry.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3X upper limit of normal (ULN) or bilirubin ≤ 2.5 ULN within 45 days prior to study entry.
- Glomerular filtration rate (GFR) \> 59 as calculated by Modification of Diet in Renal Disease (MDRD) equation within 45 days prior to study entry.
Exclusion
- Prior receipt of etravirine, dapivirine, or rilpivirine (Edurant), or Complera.
- Evidence of any of the resistance-associated mutations listed below on genotype testing performed within 90 days of study entry. Any pending resistance testing ordered prior to study entry must be available for review by the investigator prior to enrollment. Major resistance mutations include:
- Any of the following nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations: V90I, A98G, L100I, K101E/H/P/Q, K103H/S/T, V106A/I/M, V108I, E138A/G/K/Q, V179D/E/F/G/I/T, Y181C/I/V, Y188C/H/L, V189I, G190A/C/E/Q/S, H221Y, P225H, F227C/L, M230I/L, P236L, K238N/T, K103N.
- Any of the following NRTI mutations: M184V/I, K70E/R, K65R, M41L, 69 insert, L210W, T215Y/F, K219Q/E, L74V.
- Pregnancy
- Breastfeeding
- Any condition which, in the opinion of the investigator, would be likely to interfere with ability to take the study medications appropriately and comply with the study protocol.
- Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 30 days prior to study entry.
- NOTE: Routine standard of care, including hepatitis B, influenza, pneumococcus, and tetanus vaccines are permitted.
- Current active illness requiring systemic treatment and/or hospitalization until the individual completes therapy or, in the opinion of the investigator, is clinically stable on therapy for at least 7 days prior to study entry.
- Life expectancy of less than 6 months.
- Acute viral hepatitis.
- Known allergy/hypersensitivity to components of the study drugs or their formulations.
- Use of any medications that are prohibited during the study period (see Section 8.1 of the protocol - Prohibited Medications).
- Refusal by an individual who is taking anti-depressant medications to allow the investigator or Primary HIV Care provider to communicate with his/her psychiatrist/Mental Health clinician regarding the initiation of study medications in those cases where co-administration of study drugs may alter anti-depressant drug levels.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00959894
Start Date
September 1 2009
End Date
May 1 2014
Last Update
June 6 2016
Active Locations (3)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
3
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157