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Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia


Phase 3
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, HIV Infections

Thank you

Trial Information

Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Inclusion Criteria


Inclusion Criteria

Patient must have:

- Confirmed diagnosis of AIDS (CDC definition).

- Documented weight loss or anorexia.

- Life expectancy = or > 20 weeks.

- The perception that the weight loss is a detriment to their well-being.

- Ability to provide informed consent, read and write English.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

- Dementia or evidence of mental incompetence which would preclude compliance with the
protocol.

- Severe diarrhea defined as 5 or more watery stools per day for at least 7 days.

- Active uncontrolled systemic infections at the start of treatment.

- Patients may not be entered for at least 2 weeks after acute infection.

- Clinical or radiologic evidence of ascites or pleural effusions.

Patients with the following are excluded:

- Obstruction to food intake or impaired digestive/absorptive functions.

- Contraindications to megestrol acetate (poorly controlled hypertension or heart
failure or deep vein thrombosis).

- Inability to consent or be available for close follow-up.

- Active systemic infections at the start of treatment.

- Clinical or radiologic evidence of ascites or pleural effusions.

- Patients who have been hospitalized or have suffered an exacerbation of their illness
associated with weight loss within the past 2 weeks are excluded.

- Menstruating female patients are excluded.

Prior Medication:

Excluded:

- Corticosteroids.

- Anabolic steroids.

- Marijuana.

- Megestrol acetate.

- Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have
been previously treated with AZT and failed or may currently be receiving AZT for at
least 8 weeks.)

Patients may not be started on any therapy designed to treat the underlying HIV infection
or which may have a major impact on appetite and/or weight gain.

- Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have
been previously treated with AZT and failed or may currently be receiving AZT for at
least 8 weeks.)

History of substance abuse and questionable current and future abstinence.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

025B

NCT ID:

NCT00002067

Start Date:

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • HIV Infections
  • Body Weight
  • T-Lymphocytes
  • Nutritional Status
  • Megestrol
  • Acquired Immunodeficiency Syndrome
  • Anorexia
  • Cachexia
  • Energy Intake
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Anorexia
  • Cachexia

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Palo Alto Veterans Adm Med Ctr / Stanford UnivPalo Alto, California  94304
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Northwestern Univ Med SchoolChicago, Illinois  60611
Univ of South FloridaTampa, Florida  33612
Summitt Med Ctr / San Francisco Gen HospOakland, California  94609
SUNY / Health Sciences Ctr at SyracuseSyracuse, New York  13210
Denver Public Health DeptDenver, Colorado  80204
San Francisco Veterans Administration Med CtrSan Francisco, California  94121
Dr Mark GoldsteinLos Angeles, California  90048
Eisenhower Med CtrRancho Mirage, California  92270
UCD Med CtrSacramento, California  95817
Miami Veterans Administration Med CtrMiami, Florida  33125
Northwest Family Ctr at the Harbor View Med CtrSeattle, Washington  98104