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Completed

NCT Number: NCT00737204

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

This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria.

Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function, and self-report scales will be used to determine symptoms of depression and fatigue. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Primary care doctor does not approve of study participation
  • Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection 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 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 Scale (HAM-D) score >24
  • History or current psychosis or bipolar disorder
  • Pregnant or breastfeeding
  • Significant untreated insomnia (score >3 on HAM-D insomnia items)
  • Currently taking psychostimulant medication or past nonresponse to modafinil
  • Has no alternative viable antiretroviral regimen after the current one
  • Left ventricular hypertrophy; mitral valve prolapse

Treatment and study plan

Armodafinil

Drug

Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.

Other names: Nuvigil

Placebo

Drug

Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy

Other names: Sugar pill

Primary outcomes

  1. Fatigue Severity Scale(FSS) Outcome

    Time frame: Measured at baseline and Weeks 4

    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 9-63, with a higher score indicating greater impairment due to fatigue.

  2. Role Function Scale

    Time frame: Measured at Baseline and Week 4

    The Role Function Scale includes 10 items drawn from the Short Form 36-item 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 10-50.

Secondary outcomes

  1. CD4 Cell Count

    Time frame: Measured at baseline and Week 4

    Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.

  2. HIV Viral Load

    Time frame: Measured at baseline and Week 4

    HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay's lowest limit of detectability during the study.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Armodafinil Treatment for Fatigue in HIV+ Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2008
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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