Trial record 17 of 27 for:    " December 14, 2011":" January 13, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Adriana Andrade, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01500096
First received: December 14, 2011
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine whether American ginseng is effective in the treatment of HIV-associated fatigue.


Condition Intervention Phase
HIV/AIDS-associated Fatigue
Drug: American ginseng
Dietary Supplement: Placebo for American ginseng
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Multiple-Dose Escalation Clinical Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in Fatigue Severity Score [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Fatigue Severity Score from baseline to end of four weeks of treatment


Secondary Outcome Measures:
  • Additional questionnaire will be used to quantify fatigue, quality of life, symptoms of depression, sleep quality, virologic, immunologic, and inflammatory markers. [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in the Brief Fatigue Inventory from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Epworth Sleepiness Scale score from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Patient Health Questionnaire score from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Insomnia Severity Index Score from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Medical Outcomes Study HIV Health Survey score from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in Clinical Global Impressions of Change Scale score from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in IL-6 and soluble receptors of TNF α 1 and 2 (sTNFR1 and sTNFR2) from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: Yes ]
    Change in CD4 cell count from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to end of four weeks of treatment ] [ Designated as safety issue: Yes ]
    Change in plasma HIV RNA from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to end of four weeks of treatment ] [ Designated as safety issue: Yes ]
    Adverse events in intervention (American ginseng) and control arms (placebo) from baseline to end of four weeks of treatment

  • Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]
    Change in PROMIS fatigue score from baseline to end of four weeks of treatment


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: American ginseng 1000 mg/day
4-week of American ginseng 1000 mg/day every morning
Drug: American ginseng
American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
Other Name: Panax quinquefolius
Placebo Comparator: Placebo for American ginseng 1000 mg/day
4-week of placebo for American ginseng 1000 mg/day every morning
Dietary Supplement: Placebo for American ginseng

Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Other Name: Placebo for American ginseng
Active Comparator: American ginseng 3000 mg/day
4-week of American ginseng 3000 mg/day every morning
Drug: American ginseng
American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
Other Name: Panax quinquefolius
Placebo Comparator: Placebo for American ginseng 3000 mg/day
4-week of placebo for American ginseng 3000 mg/day every morning
Dietary Supplement: Placebo for American ginseng

Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Other Name: Placebo for American ginseng

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. HIV-infected men and women, ≥18 years of age
  2. HIV-1 infection documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western blot at any time prior to study entry; or documentation of ongoing HIV/AIDS care, or treatment for AIDS, or previous positive HIV serology at any time prior to study entry
  3. On stable antiretroviral therapy for at least three months
  4. Undetectable plasma HIV RNA using conventional assays with lower limits of quantification (20-75 copies/ml) obtained within 30 days prior to entry
  5. The following laboratory values obtained within 30 prior to study entry:

    Absolute neutrophil count (ANC) ≥750/mm3 Hematocrit ≥30 Platelet count ≥40,000/mm3 Calculated creatinine clearance (CrCl) ≥50 mL/min, as estimated by the Cockcroft-Gault equation* AST (SGOT), ALT (SGPT), and alkaline phosphatase <3 x ULN total bilirubin ≤2.5 x ULN

    NOTE: If the potential subject is taking an atazanavir-containing regimen at the time of screening, total bilirubin ≤5 x ULN is acceptable

    * Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/common/utilities/calculators/ccc.html

  6. Clinically significant fatigue (≥4.5 on the FSS)
  7. PHQ-9 Questionnaire score <10
  8. ISI Questionnaire <14
  9. On stable psychiatric medications for at least 8 weeks prior to enrollment.
  10. Ability and willingness of subject to provide a signed informed consent and comply with all study requirements
  11. Laboratory values and physical examination as judged by the principal investigator to be safe to participate
  12. Females of reproductive potential (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, or bilateral oophorectomy or tubal ligation) will need a negative serum or urine pregnancy test within 30 days prior to entry.

    NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and menopause is self-reported history.

  13. All potential subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/ partner must reliable methods of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormone-based contraceptive) while receiving study treatment. Subjects will be encourage to use a barrier method of contraception (e.g. condoms) along with hormonal contraceptives during administration of American ginseng.

EXCLUSION CRITERIA

  1. Untreated hypothyroidism (TSH >4.5 uIU/ml)
  2. Untreated or undertreated hypogonadism (calculated free testosterone below The lower limit of normal)
  3. Untreated or under-treated major depressive disorder
  4. No change in testosterone therapy within 6 weeks prior to screening
  5. As determined by the investigator, history of chronic or acute medical condition that in the opinion of the investigator would jeopardize safety of subjects participating in this study
  6. Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator
  7. Known allergy/sensitivity or any hypersensitivity to components of American ginseng
  8. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence or subject compliance with study requirements (stable methadone treatment allowed)
  9. Current use or requirement for any medications prohibited with study treatment including warfarin. (Lists of prohibited medications are contained in the Prohibited Medications Section of the protocol)
  10. Pregnancy or breastfeeding
  11. Use of any immunomodulator (e.g., interferons, interleukins, systemic corticosteroids, cyclosporine), vaccine, or investigational therapy within 30 days prior to study entry
  12. Treatment with investigational study drugs/vaccines
  13. Co-enrolment in observational trials is allowed if the blood volume requirement does not exceed the Red Cross limits specified for this clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500096

Contacts
Contact: Adriana Andrade, MD, MPH, FACP 410-614-4036 aandrade@jhmi.edu
Contact: Todd Brown, MD, PhD 443-756-5302 tbrown27@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Margene Kenedy, NP    410-614-7392    mkenna@jhmi.edu   
Contact: Adriana Andrade, MD, MPH, FACP    410-614-4036    aandrade@jhmi.edu   
Principal Investigator: Adriana Andrade, MD, MPH, FACP         
Sub-Investigator: Todd Brown, MD, PhD         
Sub-Investigator: Adrian Dobs, MD         
Sub-Investigator: Brent Bauer, MD         
Sub-Investigator: Jeff Sloan, PhD         
Sub-Investigator: Jeffrey Hsu, MD         
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications:
Responsible Party: Adriana Andrade, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01500096     History of Changes
Other Study ID Numbers: 5R01AT005526-03
Study First Received: December 14, 2011
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
HIV/AIDS
plasma HIV RNA
Fatigue
American ginseng
Panax quinquefolius
Fatigue Severity Scale
CD4 count
cytokines
IL-6
sTNFR1
sTNFR2

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014