Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS

NCT00118378 | Completed Phase 4 Results DMC

• 3 other identifiers: #4839R01MH072383-01DAHBR 9A-ASNM
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.

Conditions

HIV Infections; Fatigue

Keywords

HIV; AIDS; Modafinil; Depression

Outcome Measures

Primary Outcomes (2)

• Fatigue Severity Scale (FSS)

  The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.

  Measured at baseline and Week 4

• Role Function Scale Outcome

  The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.

  Measured at baseline and Week 4

Secondary Outcomes (2)

• CD4 Cell Count

  Measured at baseline and Week 4

• HIV RNA Viral Load

  Measured at baseline and Week 4

Study Arms (2)

Modafinil

EXPERIMENTAL

Participants will take modafinil for 4 weeks.

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Participants will take placebo for 4 weeks.

Drug: Placebo

Interventions

Modafinil DRUG

50 mg per day, increasing to 200 mg per day as clinically indicated

Also known as: Provigil

Modafinil

Placebo DRUG

50 mg per day, increasing to 200 mg per day as clinically indicated

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75
• HIV+
• Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
• Fatigue duration for 3+ months
• English-speaking
• Able to give informed consent
• Fecund women uses barrier method of contraception

You may not qualify if:

• Primary care doctor does not approve of study participation
• Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection \[O.I.\] in past month)
• Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
• Untreated hypothyroidism (thyroid stimulating hormone \[TSH\] over 5 IUI/mL)
• Untreated and uncontrolled hypertension
• Clinically significant anemia (hematocrit \<30%)
• Started testosterone or nandrolone in past 6 weeks
• Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
• Untreated or under-treated major depressive disorder
• Started antidepressant medication within past 6 weeks
• Substance abuse/dependence (past 4 months)
• Regular and frequent cannabis use (\> twice/week regularly)
• Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale (HAM-D) \>24
• History or current psychosis or bipolar disorder
• Pregnant or breastfeeding

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• Rabkin JG, McElhiney MC, Rabkin R, Ferrando SJ. Modafinil treatment for fatigue in HIV+ patients: a pilot study. J Clin Psychiatry. 2004 Dec;65(12):1688-95. doi: 10.4088/jcp.v65n1215.

  PMID: 15641875 BACKGROUND

• Rabkin JG, McElhiney MC, Rabkin R, McGrath PJ. Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study. J Clin Psychiatry. 2010 Jun;71(6):707-15. doi: 10.4088/JCP.09m05171bro. Epub 2010 May 4.

  PMID: 20492840 RESULT

Related Links

• Click here for a related study currently recruiting participants.

MeSH Terms

Conditions

HIV Infections; Fatigue; Acquired Immunodeficiency Syndrome; Depression

Interventions

Modafinil; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Limitations and Caveats

This study was conducted at a single site in an urban setting where most patients have good access to medical care. Women were under-represented despite outreach efforts.

Results Point of Contact

• Title: Dr. Judith Rabkin
• Organization: New York State Psychiatric Institute

jgr1@columbia.edu

212.543.5762

Study Officials

• Judith G. Rabkin, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 11, 2005
• Study Start: December 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 10, 2017
• Results First Posted: June 9, 2014

Record last verified: 2017-03

Locations

US (1)