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Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia


Phase 2
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, HIV Infections

Thank you

Trial Information

Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 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.

Prior Medication:

Allowed:

- Ganciclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

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

- 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.

Concurrent Medication:

Excluded:

- 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 eight weeks. (Patients may
have been previously treated with AZT and failed or may currently be receiving AZT
for at least 8 weeks.)

Patients with the following are excluded:

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

- Contraindications to high-dose 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.

- 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.

- Clinical or radiologic evidence of ascites or pleural effusions.

- 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 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.) 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:

025A

NCT ID:

NCT00002300

Start Date:

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • HIV Infections
  • T-Lymphocytes
  • Megestrol
  • Dose-Response Relationship, Drug
  • Acquired Immunodeficiency Syndrome
  • Anorexia
  • Cachexia
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Anorexia
  • Cachexia

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
George Washington Univ Med CtrWashington, District of Columbia  20037
Northwestern Univ Med SchoolChicago, Illinois  60611
Univ of PennsylvaniaPhiladelphia, Pennsylvania  19104
Denver Public Health DeptDenver, Colorado  80204
Veterans Administration Med CtrWashington, District of Columbia  20422
Eisenhower Med CtrRancho Mirage, California  92270
Miami Veterans Administration Med CtrMiami, Florida  33125
Birmingham Veterans Administration Med Ctr / Univ of AlabamaBirmingham, Alabama  35233
Dr NS TchekmedyianLong Beach, California  90801
Dr Stephen J Gabin JrLos Angeles, California  90067
Albany Med College / AIDS Treatment CtrAlbany, New York  12203
Community Research Initiative on AIDSNew York, New York  10010
Saint Vincent's Hosp and Med CtrNew York, New York  10011
Audie L Murphy Veterans Administration HospSan Antonio, Texas  78284