Phase 2
Completed N=96
American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial
HIV/AIDS-associated Fatigue
Source: ClinicalTrials.gov NCT01500096 ↗
Enrolled (actual)
96
Serious AEs
10.4%
Results posted
Jun 2018
Primary outcomePrimary: Change in Fatigue Severity Score (FSS) — -24.7; -16.3; -16.9; -21.6 units on a scale — p=0.15
Summary
The purpose of this study is to determine whether American ginseng is effective in the treatment of HIV-associated fatigue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fatigue Severity Score (FSS) |
-24.7; -16.3; -16.9; -21.6 | 0.15 |
| SECONDARY Change in the Brief Fatigue Inventory |
-44.2; -26.5; -42.7; -37.9 | 0.1329 |
| SECONDARY Change in Epworth Sleepiness Scale |
-5.74; -6.35; -6.97; -5.93 | 0.7454 |
| SECONDARY Change in Patient Health Questionnaire 9 |
-5.52; -5.59; -2.87; -3.86 | 0.6818 |
| SECONDARY Change in Insomnia Severity Index |
-6.9; -5.47; -3.43; -3.57 | 0.17 |
| SECONDARY Change in Medical Outcomes Study HIV Health Survey |
22.4; 17.6; 24.0; 23.1 | 0.7884 |
| SECONDARY Changes in Clinical Global Impressions |
3; 3; 7; 0 | 0.9885 |
| SECONDARY Inflammatory Markers |
0.22; 0.53; 0.079; 0.33; 19.5; -15.5 | 0.60 |
| SECONDARY Change in CD4 Cell Count |
3.45; 56.6; -23.1; 34.4 | 0.31 |
| SECONDARY Change in Plasma HIV RNA |
1.94; -0.06; 1.32; 0.0 | 0.18 |
| SECONDARY Change in PROMIS Fatigue |
-12.5; -11.1; -11.4; -9.49 | 0.47 |
| SECONDARY Number of Participants With Adverse Events in the Ginseng and Placebo Arms |
30; 16; 31; 13 | — |
Eligibility Criteria
INCLUSION CRITERIA
- 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 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
Data sourced from ClinicalTrials.gov (NCT01500096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.