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

NCT01500096 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00071671
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV/AIDS-associated Fatigue

Keywords

Fatigue; HIV/AIDS; American ginseng; Panax quinquefolius; Fatigue Severity Scale; CD4 count; plasma HIV RNA; cytokines; IL-6; sTNFR1; sTNFR2

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Severity Score (FSS)

  Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.

  From baseline to week 4 (28 days of study drugs)

Secondary Outcomes (11)

• Change in the Brief Fatigue Inventory

  Change in BFI scores from baseline to week 4 (28 days of study drugs)

• Change in Epworth Sleepiness Scale

  From baseline to week 4 (28 days of study drugs)

• Change in Patient Health Questionnaire 9

  From baseline to week 4 (28 days of study drugs)

• Change in Insomnia Severity Index

  From baseline to week 4 (28 days of study drugs)

• Change in Medical Outcomes Study HIV Health Survey

  From baseline to week 4 (28 days of study drugs)

Study Arms (4)

American ginseng 1000 mg/day

ACTIVE COMPARATOR

4-week of American ginseng 1000 mg/day every morning

Drug: American ginseng

Placebo for American ginseng 1000 mg/day

PLACEBO COMPARATOR

4-week of placebo for American ginseng 1000 mg/day every morning

Dietary Supplement: Placebo for American ginseng

American ginseng 3000 mg/day

ACTIVE COMPARATOR

4-week of American ginseng 3000 mg/day every morning

Drug: American ginseng

Placebo for American ginseng 3000 mg/day

PLACEBO COMPARATOR

4-week of placebo for American ginseng 3000 mg/day every morning

Dietary Supplement: Placebo for American ginseng

Interventions

American ginseng DRUG

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.

Also known as: Panax quinquefolius

American ginseng 1000 mg/day; American ginseng 3000 mg/day

Placebo for American ginseng DIETARY_SUPPLEMENT

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

Placebo for American ginseng 1000 mg/day; Placebo for American ginseng 3000 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected men and women, ≥18 years of age
• 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
• On stable antiretroviral therapy for at least three months
• Undetectable plasma HIV RNA using conventional assays with lower limits of quantification (20-75 copies/ml) obtained within 30 days prior to entry
• 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\* aspartate amino transferase (AST) serum glutamic oxalacetic transaminase (SGOT), amino alanine transferase (ALT) serum glutamic-pyruvic transaminase (SGPT), and alkaline phosphatase \<3 x upper limit of normal (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
• Clinically significant fatigue (≥4.5 on the FSS)
• PHQ-9 Questionnaire score \<10
• ISI Questionnaire \<14
• On stable psychiatric medications for at least 8 weeks prior to enrollment.
• Ability and willingness of subject to provide a signed informed consent and comply with all study requirements
• Laboratory values and physical examination as judged by the principal investigator to be safe to participate
• 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.

You may not qualify if:

• Untreated hypothyroidism (TSH \>4.5 milli-international units per liter (mIU/L))
• Untreated or undertreated hypogonadism (calculated free testosterone below The lower limit of normal)
• Untreated or under-treated major depressive disorder
• No change in testosterone therapy within 6 weeks prior to screening
• 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
• Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator
• Known allergy/sensitivity or any hypersensitivity to components of American ginseng
• 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)
• 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)
• Pregnancy or breastfeeding
• Use of any immunomodulator (e.g., interferons, interleukins, systemic corticosteroids, cyclosporine), vaccine, or investigational therapy within 30 days prior to study entry
• Treatment with investigational study drugs/vaccines
• Co-enrolment in observational trials is allowed if the blood volume requirement does not exceed the Red Cross limits specified for this clinical trial

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Andrade AS, Hendrix C, Parsons TL, Caballero B, Yuan CS, Flexner CW, Dobs AS, Brown TT. Pharmacokinetic and metabolic effects of American ginseng (Panax quinquefolius) in healthy volunteers receiving the HIV protease inhibitor indinavir. BMC Complement Altern Med. 2008 Aug 19;8:50. doi: 10.1186/1472-6882-8-50.

  PMID: 18713456 BACKGROUND

• Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6.

  PMID: 19415341 BACKGROUND

MeSH Terms

Conditions

Fatigue; Acquired Immunodeficiency Syndrome

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Adriana Andrade
• Organization: Johns Hokpins University

aandrade@jhmi.edu

410-955-7287

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 26, 2011
• Study Start: February 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 10, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-06

Locations

US (1)