Clinical trial NCT01184456 (phase 2, status: completed)
Conditions: hiv infection, gastrointestinal symptoms
ICD codes: Z21
Drugs: placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or non-pregnant, non-lactating female.

          -  Adults 18 years or older.

          -  Is able to provide written, informed consent to participate in the study.

          -  Serological documentation of HIV infection at any time prior to study entry and is
             clinically stable.

          -  Stable CD4 count greater than or equal to 250 cells/cubic mm for six months prior to
             study entry (+/- 50 cells/cubic mm).

          -  HIV-1 RNA ≤50 copies/mL for six months prior to study entry.

          -  Karnofsky performance status - 60%.

          -  Adequate laboratory parameters within the last 30 days:

               1. absolute neutrophil count >1000 cells/cubic mm

               2. hemoglobin >9.0 g/dL

               3. platelets >75,000/cubic mm

               4. creatinine <1.5 x upper limit of normal

               5. SGOT/SGPT <3.0 x upper limit of normal

               6. bilirubin <2.0 mg/dL

          -  Patients with documented GI symptoms to include but are not limited to: flatulence,
             diarrhea, bloating, gastroesophageal reflux disease, nausea, and constipation.

          -  If females are of childbearing potential, they must be practicing an effective method
             of contraception and agree to use birth control while on protocol and for 1 month
             after completion of study. Women of Child Bearing Potential (WOCBP) must have a
             negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
             units of HCG) within 72 hours prior to start of study medication. WOCBP include any
             female who has experienced menarche and who has not undergone successful surgical
             sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is
             not. postmenopausal [defined as amenorrhea for 12 consecutive months; or women on
             hormone replacement therapy (HRT) with documented serum follicle stimulating hormone
             (FSH) level > 35 mIU/mL]. Even women who are using oral, implanted or, injectable
             contraceptive hormones or mechanical products such as an intrauterine device or
             barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
             abstinence or where partner is sterile (e.g., vasectomy), should be considered to be
             of child bearing potential.

          -  Must agree to practice protected sexual activity (via barrier method) during course of
             the study.

          -  In the opinion of the investigator, is willing and able to comply with the study
             requirements.

        Exclusion Criteria:

          -  Active opportunistic infection, which is progressive, or imminently disabling or life
             threatening, in the judgment of the Principal Investigator with exception of Kaposi
             Sarcoma.

          -  Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the
             preceding 3 weeks (subjects who have received intralesional chemotherapy will not be
             excluded, however).

          -  Any antibiotic therapy within 30 days of enrollment

          -  Any probiotic formulation within 30 days of enrollment

          -  Any immunization within 30 days of enrollment

          -  Known history of allergic reactions to any of the investigational products or their
             ingredients.

          -  Chronic treatment with immunosuppressant drugs, including corticosteroids, except for
             the treatment of adrenal insufficiency. Topical steroids are permitted.

          -  History of or known current malabsorption syndrome.

          -  Any grade 3 or 4 lab abnormalities as defined by a standardized grading scheme based
             on the DAIDS table (see Appendix B) with the following exceptions:

          -  Pre-existing diabetes with glucose toxicity elevations ≥ grade 3

          -  Triglyceride or total cholesterol elevations ≥ grade 3

          -  Clinical or laboratory evidence of clinically significant liver impairment/
             dysfunction, disease or cirrhosis.

          -  Life expectancy < 6 months in the opinion of the investigator.

          -  Active substance abuse or significant psychiatric illness that in the opinion of the
             investigator might interfere with study compliance.

          -  Female subject of childbearing potential not using effective non-hormonal birth
             control methods or not willing to continue practicing these birth control methods from
             screening until the last trial related activity.

          -  Subject is pregnant or lactating.

          -  Any condition that in the Principal Investigator's opinion may render the subject
             unable to complete the study or which may pose significant risk to the subject.