RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL TO ASSESS THE IMPACT OF EXTENDED-RELEASE NALTREXONE ON HIV TRETAMENT OUTCOMES AMONG HIV-1 INFECTED MEN WHO HAVE SEX WITH MEN AND TRANSGENDER WOMEN WITH ALCOHOL USE DISORDERS IN LMA, PERU.

Instituto de Investigacion del Cancer Fred Hutchinson, Estados Unidos,0 个研究点目标入组 0 人开始时间: 2013年2月14日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. AGE 18 YEARS OR OLDER.
•2. CONFIRMED HIV INFECTION, EITHER THROUGH DETECTION OF HIV ANTIBODY OR HIV-1 RNA OR P24 ANTIGEN.
•3. RECENT DIAGNOSIS OF HIV INFECTION IN THE PREVIOUS 90 DAYS.
•4. BIOLOGICALLY MALE AND IDENTIFYING AS MSM OR TRANSGENDER WOMAN IN THE PREVIOUS 12 MONTHS.
•5. MEET DSM-IV CRITERIA FOR HAVING AN AUD, SPECIFICALLY ALCOHOL DEPENDENCE OR HAZARDOUS DRINKING (BASED ON AN AUDIT SCORE ≥ 8)
•6. NO EVIDENCE OF ACUTE ALCOHOL WITHDRAWAL SYNDROME (BASED IN A CLINICAL INSTITUTE WITHDRAWAL ASSESSMENT FOR ALCOHOL-CIWA-AR-SCALE).
•7. NO PARTICIPATION IN MEDICATION-ASSISTED THERAPY AND/OR A PSYCHOTHERAPY RESEARCH TRIAL FOR TREATMENT OF AUD IN THE PREVIOUS 30 DAYS.
•8. WILLING AND ABLE TO PROVIDE INFORMED CONSENT.
•9. NO PLANS TO HAVE SURGERY WITHIN THE NEXT 6 MONTHS.
•10. NO PLANS TO TRAVEL EXTENSIVELY FOR THE YEAR:
•11. ABLE TO PROVIDE CONTACT INFORMATION, INCLUDING:
•. ONE OR MORE PHONE NUMBER (CELL AND/OR HOME) AND/OR A STREET ADDRESS OF
•RESIDENCE FOR THEMSELVES; AND
•. PERSONAL CONTACT INFORMATION (IDEALLY FROM TWO OR MORE PEOPLE) WHO WOULD KNOW THEIR WHEREABOUTS DURING THE STUDY PERIOD.

•1. ACTIVE CLINICALLY SIGNIFICANT MEDICAL PROBLEMS, INCLUDING AN ACTIVE OPPORTUNISTIC INFECTION (E.G., UNEXPLAINED FEVER, WEIGHT LOSS, CHRONIC COUGH) OR HAVING AN EMERGENT NEED HOSPITALIZATION AT THE TIME OF SCREENING (E.G., SUICIDAL OR HOMICIDAL IDEATION UNSTABLE ANGINA PECTORIS, ETC.).
•2. ACTIVE HEPATITIS B INFECTION DETERMINED BY THE FOLLOWING HEPATITIS SEROLOGICAL RESULTS: TOTAL HEPATITIS B CORE ANTIBODY (ANTI-HBC) POSITIVE, HEPATITIS B SURFACE ANTIBODY (ANTI-HBS) NEGATIVE AND HEPATITIS B SURFACE ANTIGEN POSITIVE AT THE SCREENING VISIT.
•3. CHILDS-PUGH CLASS C CIRRHOSIS.
•4. RECEIVING OPIOID PRESCRIPTION NARCOTICS OR HAS PAIN SYNDROME NECESSITATING FUTURE USE OF OPIOIDS.
•5. POSITIVE URINE TEST FOR OPIOIDS.
•6. INABILITY TO RECEIVE AN INTRAMUSCULAR GLUTEAL INJECTION.
•7. CONCOMITANT PARTICIPATION IN A CLINICAL TRIAL OR COHORT STUDY OTHER THAN SUB-STUDIES OF THIS PROTOCOL, INCLUDING AIM 1 OF THE SEEK TEST TREAT AND RETAIN PROTOCOL.
•8. INCARCERATION OR INSTITUCIONALIZATION OR CHARGERS ANTICIPATING ARREST.
•9. AT ENROLLEMENT HAVING ANY OTHER CONDITION THAT, BASED ON THE OPINION OF THE INVESTIGATOR OR DESIGNEE , WOULD PRECLUDE PROVISION OF INFORMED CONSENT, MAKE PARTICIPATION IN THE STUDY UNSAFE; COMPLICATE INTERPRETATION OF STUDY OUTCOME DATA; OR OTHERWISE INTERFERE WITH ACHIEVING THE STUDY OBJECTIVES.

发起方

Instituto de Investigacion del Cancer Fred Hutchinson, Estados Unidos,