Table 3.
Examples of criteria ratings. A, B and C are co-authors at UAB and NU; 1-4 correspond to categories from Table 2. * indicates criteria for which there was complete or near agreement, included in further analysis. Raters used "x" or "?" to indicate that the meaning of the criterion was unclear or that the categorization was unknown.
| UAB Raters | NU Raters | Criteria | ||||
|---|---|---|---|---|---|---|
| A | B | C | A | B | C | |
| 1 | 1 | 1 | 4 | 4 | 4 | Abnormal liver function as defined in the protocol at Screening * |
| 1 | 1 | 1 | 1 | 1 | 1 | absolute neutrophil count <1,000/mm3 * |
| 1 | 1 | 1 | 3 | 3 | 1 | allergy to starch powder or iodine. * |
| 1 | 1 | 1 | 1 | 1 | 1 | Anti-cancer treatment prior to trial entry * |
| 1 | 1 | 1 | 1 | 1 | 1 | BMI 40 - 80 kg / m2 * |
| 1 | 1 | 2 | 1 | 1 | 1 | digoxin within 6 months of starting treatment. * |
| 1 | 1 | 3 | 1 | 1 | 1 | immunosuppressants within 6 months of starting treatment |
| 1 | 1 | 3 | 1 | 1 | 1 | medication that is either moderate or strong inhibitor or inducer of cytochrome P450 (CYP)3A4 or is a sensitive substrate of other cytochrome P450 |
| 1 | 1 | 2 | 1 | 1 | 2 | <Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs |
| 1 | 2 | 2 | 2 | 2 | 2 | currently being treated for secondary hyperparathyroidism * |
| 2 | 3 | 1 | 2 | 2 | 4 | Chronic heart failure New York Heart Association (NYHA) class IV |
| 1 | 4 | x | 4 | 4 | 4 | For women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment |
| 2 | 2 | 2 | 2 | 2 | 2 | Active or untreated latent tuberculosis (TB) * |
| 2 | 2 | 2 | 2 | 2 | 4 | Pregnancy or lactation period * |
| 2 | 2 | 4 | 4 | 4 | 4 | Women of childbearing potential that are pregnant, intend to become pregnant, or are lactating |
| 2 | 3 | 4 | 2 | 2 | 1 | Dermal disorder including infection at anticipated treatment sites in either axilla. |
| 2 | 3 | 4 | 4 | 4 | 4 | Evidence of lens opacity or cataract at the Screening |
| 3 | 1 | 4 | 4 | 4 | 1 | Presence of corneal and conjunctival staining. |
| 3 | 3 | 3 | 1 | 1 | 1 | HDSS score of 3 or 4. * |
| 3 | 3 | 3 | 4 | 4 | 3 | Prior treatment with any investigational drug within the preceding 4 weeks prior to study entry.* |
| 3 | 3 | 3 | 4 | 4 | 4 | Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF * |
| 3 | 3 | 4 | 4 | 4 | 4 | person deprived of liberty by judicial or administrative decision * |
| 3 | 4 | 4 | 3 | 3 | 4 | Able to swallow tablets * |
| 3 | 4 | 4 | 3 | 3 | 3 | good health * |
| 3 | 4 | 4 | 3 | 3 | 3 | good overall physical constitution * |
| 3 | 4 | 4 | 3 | 3 | 3 | Legal incapacity or limited legal capacity * |
| 3 | 4 | 4 | 4 | 4 | 4 | Living conditions-suggesting an inability to track all scheduled visits by the protocol * |
| 3 | 4 | 4 | 4 | 4 | 4 | Maintenance of a diet consisting of 40 g of carbohydrate per day within 3 months of screening* |
| 3 | ? | 3 | 4 | 4 | 4 | must have completed Part 2 of the base study |
| 4 | 4 | 4 | 4 | 4 | 4 | Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * |
| 4 | 4 | 4 | 4 | 4 | 4 | Facial hair * |
| 4 | 4 | 4 | 4 | 4 | 4 | Parents/children who refuse to participate in the study * |
| 4 | 4 | 4 | 4 | 4 | 4 | Unwillingness/inability to limit antioxidant supplement use to study-provided supplements * |
| 4 | 4 | 4 | 4 | 4 | 4 | Willing to be examined * |
| 4 | 4 | 4 | 4 | 4 | 4 | Current alcohol or substance use judged by the investigator to potentially interfere with study compliance |