Clinical trial NCT02121756 (phase 1/phase 2, status: completed)
Conditions: hiv infection
ICD codes: Z21
Drugs: dipyridamole, placebo, then dipyridamole
SMILES: OCCN(CCO)C1=NC2=C(N=C(N=C2N2CCCCC2)N(CCO)CCO)C(=N1)N1CCCCC1, OCCN(CCO)C1=NC2=C(N=C(N=C2N2CCCCC2)N(CCO)CCO)C(=N1)N1CCCCC1
Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
             chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
             confirmed by a licensed Western blot or a second antibody test by a method other than
             the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

          -  On ART for at least 12 months prior to study entry with a regimen that includes three
             or more antiretroviral medications. More information on this criterion is available in
             the protocol.

          -  Plasma HIV-1 RNA <50 copies/mL by any standard clinical assay at screening and for a
             minimum of 12 months prior to entry, confirmed by at least 2 measurements prior to
             study entry, one of which must be at least 48 weeks prior to study entry and one of
             which must be 61 days and 48 weeks prior to study entry. All plasma HIV-1 RNA
             measurements in the 12 months prior to study entry must be <50 copies/mL (with the
             exception that a single detectable measurement of ≤ 200 copies/mL is permitted if the
             RNA levels immediately before and after are <50 copies/mL).

          -  Stable ART regimen for at least 8 weeks prior to study entry and no plans to change
             ART regimen for at least 6 months following study entry.

          -  Ability and willingness to provide informed consent.

          -  In the opinion of the investigator, no medical, mental health or other condition that
             precludes participation.

          -  Laboratory values obtained within 60 days prior to entry.

               -  Hemoglobin ≥10.0 g/dL

               -  Platelet count ≥100,000/mm3

               -  INR ≤ 1.5 (for rectal tissue subset only)

               -  PTT <2x ULN (for rectal tissue subset only)

               -  AST and ALT < 2.5 x upper limit of normal (ULN)

               -  Total bilirubin < 2.5 x ULN (except if hyperbilirubinemia is secondary to
                  atazanavir).

               -  Creatinine ≤ 1.5 x ULN

               -  Hepatitis B surface antigen negative

               -  Hepatitis C antibody negative (note: subject with HCV Ab positive is eligible if
                  Hepatitis C RNA PCR (viral load) is undetectable)

          -  For females of reproductive potential, negative serum or urine pregnancy test at
             screening and within 72 hours prior to study entry. Females of reproductive potential
             include women who have not been post-menopausal for at least 24 consecutive months,
             (i.e., who have had menses within the preceding 24 months, or women who have not
             undergone surgical sterilization, specifically hysterectomy and/or bilateral
             oophorectomy).

          -  Females of reproductive potential who are participating in sexual activity that could
             lead to pregnancy must agree to use one method of acceptable contraception while
             receiving protocol-specified treatment and for 4 weeks after stopping the treatment.
             These methods include condoms (male or female) with or without a spermicidal agent;
             diaphragm or cervical cap with spermicide; intrauterine device (IUD); and
             hormone-based contraceptive.

          -  Females not of reproductive potential (girls who have not reached menarche, women who
             have been post-menopausal for at least 24 consecutive months, or women who have
             undergone surgical sterilization, e.g., hysterectomy, bilateral oophorectomy, or
             bilateral tubal ligation or salpingectomy) are eligible without requiring the use of a
             contraceptive. Self- report is acceptable documentation of sterilization, other
             contraceptive methods, and menopause.

          -  Rectal Tissue Subset only: Willing to abstain from receptive anal intercourse and
             practices involving insertion of anything in the rectum (drug, enema, penis, or sex
             toy) for 72 hours prior to rectal biopsy and for 7 days post-biopsy to minimize risk
             of bleeding complications.

        Exclusion Criteria:

          -  Pregnancy or breast-feeding.

          -  Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or
             their formulation.

          -  Known cardiovascular disease (history of MI, coronary artery bypass graft surgery,
             percutaneous coronary intervention, stroke, transient ischemic attack, peripheral
             arterial disease with ABI <0.9 or claudication).

          -  Uncontrolled type II diabetes mellitus.

          -  Known chronic inflammatory conditions such as, but not limited to, rheumatoid
             arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease
             (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune
             hepatitis, myositis, or myopathy.

          -  History of asthma requiring medical treatment within 2 years prior to study entry with
             the exception of the use of albuterol inhaler for mild intermittent asthma.

          -  Serious illness requiring systemic treatment and/or hospitalization within 14 days
             prior to entry.

          -  Use of any of the following medications for more than 3 consecutive days within the 60
             days prior to study entry:

               -  Immunosuppressives (e.g., azathioprine, corticosteroids [physiologic replacement
                  doses are allowed], cyclosporine, mycophenolate, NSAIDs (nonsteroidal
                  anti-inflammatory drugs), sirolimus, sulfasalazine, tacrolimus)

               -  Immune modulators (e.g., cytokines [e.g., IL-2], granulocyte colony stimulating
                  factor, growth hormone, tumor necrosis factor antagonists, thalidomide)

               -  Antineoplastic agents

               -  Anticoagulants (e.g., warfarin and heparin)

               -  Anti-platelet drugs (e.g., clopidogrel and aspirin)

          -  Vaccinations within 1 week prior to the pre-entry or study entry visits. Routine
             standard of care vaccinations including hepatitis A and/or B, influenza, pneumococcal,
             and tetanus are permitted if administered at least 7 days before pre-entry and entry
             evaluations.

          -  Participation on any HIV immunotherapy or therapeutic vaccination trials within 6
             months prior to study entry.

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements.

          -  Use of investigational therapies within 30 days prior to study entry.

          -  Rectal Tissue Subset only:

               -  Abnormalities of the colorectal mucosa or significant colorectal symptom(s),
                  which in the opinion of the study investigator represent a contraindication to
                  biopsy (including but not limited to presence of any unresolved injury,
                  infectious or inflammatory condition of the local mucosa, and presence of
                  symptomatic external hemorrhoids.

               -  NOTE: Abnormalities of the colorectal mucosa will be assessed at the time of the
                  enrollment flexible sigmoidoscopy. If no significant colorectal abnormalities or
                  symptoms are present then the participant will undergo the enrollment procedures.
                  If abnormalities are present then no biopsies will be performed and the
                  participant will not be enrolled into the rectal tissue subset but will continue
                  participation in the main study.

               -  Active untreated gonorrhea, or chlamydia infection within 30 days prior to study
                  entry (subjects diagnosed with rectal gonorrhea or chlamydia infection at
                  screening may be treated during the screening period provided the treatment is at
                  least 30 days prior to entry).

          -  Exclusions for spirometry testing (for participants enrolled under Version 2.0)
             Participants will not undergo pre- and post-bronchodilator spirometry if they have any
             of the following: - Abdominal or cataract surgery within 3 months.

               -  Myocardial infarction or stroke within the past 3 months.

               -  Acute onset of shortness of breath, cough, fever or heart condition such as
                  tachycardia, angina or arrhythmias with 4 weeks prior to enrollment.

               -  Increasing respiratory symptoms or febrile (temperature >100.4°F [38°C]) within 4
                  weeks of study entry.

               -  Uncontrolled hypertension defined as systolic > 160 mm Hg or diastolic > 100 mm
                  Hg from an average of two or more readings. Participant with controlled
                  hypertension may undergo spirometry.

               -  Prior history of adverse reaction to albuterol.