Clinical trial NCT01049932 (phase 1/phase 2, status: terminated)
Conditions: hiv infections
ICD codes: Z21
Drugs: tmc278la
SMILES: CC1=CC(\C=C\C#N)=CC(C)=C1NC1=CC=NC(NC2=CC=C(C=C2)C#N)=N1
Reason stopped: 
    trial closed due to additional safety information.
  
Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria within 42 days prior to the
        baseline visit:

          1. Must understand and sign a written informed consent form, prior to participation in
             any screening procedures and must comply with all study requirements

          2. Male or non-pregnant, non-lactating females of different ethnic backgrounds

          3. Age between 18 to 50 years, inclusive

          4. Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive

          5. Absence of any significant health problems on the basis of the screening procedures;
             including medical history, physical examination, vital signs, ECG

          6. Clinically significant laboratory abnormalities

          7. Willing to undergo HIV testing, HIV discussion and receive HIV test results (according
             to the "UK National Guidelines for HIV Testing 2008", www.bhiva.org)

          8. Women of childbearing potential must be using an adequate method of contraception
             (diaphragm, intrauterine device, condoms, anatomical sterility in self or partner) to
             avoid pregnancy throughout the study and for a period of at least four months after
             the study follow up visit. Oral hormonal methods and implant contraceptives are
             allowed but only in combination with the additional protection of a barrier method

          9. If sexually active male, willing to use an effective method of contraception such as
             condoms, anatomical sterility from the day of enrolment until at least four months
             after the follow up visit

         10. Likely to remain resident in the UK for the duration of the study and follow-up period

         11. Willing to consent to their personal details being entered onto The Over volunteering
             Prevention Scheme (TOPS) database

         12. Willing to provide photographic identification at each visit.

         13. Registered with a GP in the UK

        Exclusion Criteria:

        Subjects who meet any of the following exclusion criteria are not to be enrolled in this
        study.

          1. Any significant acute or chronic medical illness

          2. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations

          3. Positive blood screen for syphilis, hepatitis A (IgM) B (HBs Ag) and/or C antibodies

          4. Positive blood screen for HIV-1 and/or HIV-2 antibodies

          5. High-risk behaviour for HIV infection which is defined as having one of the following
             within six months before study day 0 (first dose):

             i. had unprotected vaginal or anal sex with a known HIV infected person or a casual
             partner ii. engaged in sex work for money or drugs iii. acquired a sexually
             transmitted disease iv. having a high risk partner either currently or in the previous
             six months

          6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of
             alcohol or drug use considered by the Investigator to be sufficient to hinder
             compliance with treatment, follow-up procedures or evaluation of adverse events

          7. Exposure to any investigational drug or placebo within 30 days of first dose of study
             drug (additional check to be made on TOPS www.tops.org.uk)

          8. History of severe drug allergy that the Investigator thinks may increase the risk of
             developing an allergic reaction to the study drug

          9. Use of any drug, including over-the-counter medications and herbal preparations,
             within two weeks prior to first dose of study drug unless approved by the Investigator

         10. Females who are pregnant or lactating

         11. Females of childbearing potential not using effective non-hormonal birth control
             methods, or not willing to practise these birth control methods for at least four
             months after the study follow up visit

         12. Males unwilling to use an effective method of contraception such as condoms,
             anatomical sterility from the day of enrolment until at least four months after the
             follow up visit