Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01500096
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2011-12-14
Brief Title:
American Ginseng to Improve HIV-Associated Fatigue A Randomized Placebo-Controlled Parallel Design Multiple-Dose Clinical Trial
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
American Ginseng to Improve HIV-Associated Fatigue A Randomized Placebo-Controlled Multiple-Dose Escalation Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether American ginseng is effective in the treatment of HIV-associated fatigue
Detailed Description:
STUDY DESIGN Chronic fatigue is a major problem for HIV-infected patients and contributes to decreased quality of life and physical functioning higher levels of psychological distress and antiretroviral non-adherence The etiology of fatigue in HIV-infected patients is unknown but changes in systemic inflammation may play a contributing role The mechanism of action of ginseng in the treatment of fatigue is also not clear but in its role as a purported adaptogen it may decrease fatigue by altering systemic inflammation Ginseng is one of the most popular botanical products in the US and is marketed to improve fatigue and vitality Our preliminary data suggested that American ginseng at 1000-2000 mgday may decrease fatigue in cancer patients HIV-infected patients frequently use ginseng in part because they perceive these therapies to be safer than more conventional therapies
We hypothesized that a standardized American ginseng formulation will improved HIV-related fatigue To test this hypothesis we propose a 6-week double-blind placebo-controlled trial parallel study of four weeks of treatment involving two doses of American ginseng or placebo 1000mgday or 3000 mgday in 120 HIV-infected patients with clinically significant fatigue as defined by their scores on the Fatigue Severity Scale Patients will be treated with American ginseng or placebo every morning for a total of two doses of 1000 mgday or 3000 mgday A smaller cohort of 12 out of 120 subjects will be enrolled initially to monitor closely for confirmed virologic failure If confirmed virologic failure is not observed enrollment will continue to the proposed 120 subjects Virologic failure is defined as two consecutive plasma viral loads 200 cells according to the 2012 Department of Health Humans Services Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents
The proposed doses of American ginseng are the same as those used in our previous trials American ginseng 1000 mgday showed efficacy in ameliorating fatigue in cancer patients The highest dose of American ginseng 3000 mgday selected for this study was derived from our previous American ginseng trial
Change on scores of the Fatigue Severity Scale FSS between American ginseng and placebo groups at baseline and treatment weeks 2 4 and 6 the last safety visit two weeks after completing the 4-week treatment period with American ginseng or placebo will be calculated The primary comparison of interest will involve the primary endpoint of the average change in the FSS scale score from baseline to the end of treatment Other instruments to supplement the FSS and further assess fatigue will be a modified version of the Brief Fatigue Inventory BFI The Epworth Sleepiness Scale ESS the Patient Health Questionnaire PHQ-9 Insomnia Severity Index ISI the Medical Outcomes Study HIV Health Survey MOS-HIV the Clinical Global Impressions CGI of Change Scale and Patient-Reported Outcomes Measurement Information System PROMIS fatigue To further elucidate the mechanism of HIV-related fatigue we will evaluate the effects of American ginseng and placebo on markers of systemic inflammation such as IL-6 and soluble receptors of tumor necrosis factor TNF α 1 and 2 sTNFR1 and sTNFR2 at baseline and weeks 2 4 and 6 cluster of differentiation 4 CD4 cell counts plasma HIV RNA levels and adverse events AEs will also be assessed for safety purposes
DURATION
The total duration of this study is 6 weeks Participants will receive American ginseng or placebo during the first 4 weeks of the study On week 6 participants will complete their final post treatment safety study visit
POPULATION AND SAMPLE SIZE
120 HIV-infected subjects 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo 3000 mgday arm
REGIMEN
This is a randomized placebo-controlled longitudinal parallel study with two doses of American ginseng As shown in the study schematic figure two doses of American ginseng or placebo 1000 or 3000 mgday will be given to 120 HIV-infected patients 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo 3000 mgday arm with clinically significant fatigue Participants will receive American ginseng or placebo for a total of 4 weeks and will be followed for a total of 6 weeks week 6 is the last safety visit 2 weeks after completing the 4-week treatment period with American ginseng or placebo
American ginseng will be continued for Grades 1 and 2 toxicities at the discretion of the investigator Treatment will be discontinued for subjects experiencing any grade 3 study drug toxicity Evaluations for the early termination visit will be completed for these subjects Participants who discontinue treatment secondary to toxicity will be followed until resolution return to baseline values or an adequate explanation can be given for their condition Subjects requiring dose modificationsreductionsinterruptions of American ginsengplacebo to manage toxicities will be followed off study drugs The total number of patients accrued hence will be 120 patients 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo American ginseng 3000 mgday arm
STUDY DURATION The total duration of this study is six weeks Participants will receive American ginseng or placebo during the first 4 weeks of the study On week 6 participants will complete their final post treatment safety study visit
STUDY AGENTINTERVENTION DESCRIPTION Two doses of American ginseng or placebo 1000 mgday or 3000 mgday every morning by mouth for a 4-week period
PRIMARY AND SECONDARY OBJECTIVES The overall objective of this study is to determine the effect of American ginseng on fatigue in HIV-infected subjects HIV-infected subjects with fatigue will be randomized to receive two doses 1000 mgday or 3000 mgday of standardized American ginseng or placebo and their levels of fatigue and quality of life will be assessed We will also quantify proinflammatory cytokines in the placebo and American ginseng-treated groups to further elucidate the mechanism of HIV-related fatigue and the effects of American ginseng on these markers
ENDPOINTS
Primary Endpoint Change in FSS total score from baseline to end of four weeks of treatment
Secondary Endpoints Change from baseline and values observed at 2 4 and 6 weeks post-baseline for the following measures BFI-global assessment score ESS score PHQ-9 total score ISI score MOS-HIV scale total score Gene Importance Calculator GIC score PROMIS fatigue scale score Serum cytokines IL-6 sTNFR1 sTNFR2 CD4 cell counts proportion with detectable plasma HIV RNA AEs will be measured using the Division of AIDS Table for Grading the Severity of Adults Adverse events
We hypothesized that a standardized American ginseng formulation will improved HIV-related fatigue To test this hypothesis we propose a 6-week double-blind placebo-controlled trial parallel study of four weeks of treatment involving two doses of American ginseng or placebo 1000mgday or 3000 mgday in 120 HIV-infected patients with clinically significant fatigue as defined by their scores on the Fatigue Severity Scale Patients will be treated with American ginseng or placebo every morning for a total of two doses of 1000 mgday or 3000 mgday A smaller cohort of 12 out of 120 subjects will be enrolled initially to monitor closely for confirmed virologic failure If confirmed virologic failure is not observed enrollment will continue to the proposed 120 subjects Virologic failure is defined as two consecutive plasma viral loads 200 cells according to the 2012 Department of Health Humans Services Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents
The proposed doses of American ginseng are the same as those used in our previous trials American ginseng 1000 mgday showed efficacy in ameliorating fatigue in cancer patients The highest dose of American ginseng 3000 mgday selected for this study was derived from our previous American ginseng trial
Change on scores of the Fatigue Severity Scale FSS between American ginseng and placebo groups at baseline and treatment weeks 2 4 and 6 the last safety visit two weeks after completing the 4-week treatment period with American ginseng or placebo will be calculated The primary comparison of interest will involve the primary endpoint of the average change in the FSS scale score from baseline to the end of treatment Other instruments to supplement the FSS and further assess fatigue will be a modified version of the Brief Fatigue Inventory BFI The Epworth Sleepiness Scale ESS the Patient Health Questionnaire PHQ-9 Insomnia Severity Index ISI the Medical Outcomes Study HIV Health Survey MOS-HIV the Clinical Global Impressions CGI of Change Scale and Patient-Reported Outcomes Measurement Information System PROMIS fatigue To further elucidate the mechanism of HIV-related fatigue we will evaluate the effects of American ginseng and placebo on markers of systemic inflammation such as IL-6 and soluble receptors of tumor necrosis factor TNF α 1 and 2 sTNFR1 and sTNFR2 at baseline and weeks 2 4 and 6 cluster of differentiation 4 CD4 cell counts plasma HIV RNA levels and adverse events AEs will also be assessed for safety purposes
DURATION
The total duration of this study is 6 weeks Participants will receive American ginseng or placebo during the first 4 weeks of the study On week 6 participants will complete their final post treatment safety study visit
POPULATION AND SAMPLE SIZE
120 HIV-infected subjects 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo 3000 mgday arm
REGIMEN
This is a randomized placebo-controlled longitudinal parallel study with two doses of American ginseng As shown in the study schematic figure two doses of American ginseng or placebo 1000 or 3000 mgday will be given to 120 HIV-infected patients 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo 3000 mgday arm with clinically significant fatigue Participants will receive American ginseng or placebo for a total of 4 weeks and will be followed for a total of 6 weeks week 6 is the last safety visit 2 weeks after completing the 4-week treatment period with American ginseng or placebo
American ginseng will be continued for Grades 1 and 2 toxicities at the discretion of the investigator Treatment will be discontinued for subjects experiencing any grade 3 study drug toxicity Evaluations for the early termination visit will be completed for these subjects Participants who discontinue treatment secondary to toxicity will be followed until resolution return to baseline values or an adequate explanation can be given for their condition Subjects requiring dose modificationsreductionsinterruptions of American ginsengplacebo to manage toxicities will be followed off study drugs The total number of patients accrued hence will be 120 patients 40 in the American ginseng 1000 mgday arm 40 in the American ginseng 3000 mgday arm 20 in the placebo 1000 mgday arm and 20 in the placebo American ginseng 3000 mgday arm
STUDY DURATION The total duration of this study is six weeks Participants will receive American ginseng or placebo during the first 4 weeks of the study On week 6 participants will complete their final post treatment safety study visit
STUDY AGENTINTERVENTION DESCRIPTION Two doses of American ginseng or placebo 1000 mgday or 3000 mgday every morning by mouth for a 4-week period
PRIMARY AND SECONDARY OBJECTIVES The overall objective of this study is to determine the effect of American ginseng on fatigue in HIV-infected subjects HIV-infected subjects with fatigue will be randomized to receive two doses 1000 mgday or 3000 mgday of standardized American ginseng or placebo and their levels of fatigue and quality of life will be assessed We will also quantify proinflammatory cytokines in the placebo and American ginseng-treated groups to further elucidate the mechanism of HIV-related fatigue and the effects of American ginseng on these markers
ENDPOINTS
Primary Endpoint Change in FSS total score from baseline to end of four weeks of treatment
Secondary Endpoints Change from baseline and values observed at 2 4 and 6 weeks post-baseline for the following measures BFI-global assessment score ESS score PHQ-9 total score ISI score MOS-HIV scale total score Gene Importance Calculator GIC score PROMIS fatigue scale score Serum cytokines IL-6 sTNFR1 sTNFR2 CD4 cell counts proportion with detectable plasma HIV RNA AEs will be measured using the Division of AIDS Table for Grading the Severity of Adults Adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None