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Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

Inclusion Criteria


Inclusion Criteria

Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be
ambulatory, and be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with unstable disease characterized by the following are excluded:

- Hospitalization within the past 14 days.

- Major opportunistic infection, current or past.

- An active infection of onset during the past 30 days, as evidenced by symptoms,
signs, or laboratory abnormalities such as:

- Temperature = or > 100.5 degrees F.

- Night sweats.

- Weight loss = or > 10 percent of body weight.

- Diarrhea (3 or more bowel movements/day).

- Persistent cough, shortness of breath, or dyspnea on exercise.

- Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a)
gradient.

- Altered mental status, seizures, or focal neurologic signs.

- Abnormal computerized tomography (CT) scan or magnetic resonance imaging (MRI)
suggestive of toxoplasmosis, peripheral mononuclear leukocytes, lymphoma, or other
focal abnormality of the central nervous system (CNS).

- Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or
other meningitis. (The decision to perform invasive tests, such as lumbar puncture,
specialized microbiological tests such as bone marrow culture for Mycobacteria or
Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI
should be based on clinical assessment of the patient.)

- Kaposi's sarcoma.

- Lymphoma; malignancy requiring chemotherapy.

- Dementia.

- Requiring hemodialysis or renal insufficiency or failure.

- Leukopenia.

- Thrombocytopenia.

Patients with the following are excluded:

- Unstable disease.

- Kaposi's sarcoma.

- Lymphoma; malignancy requiring chemotherapy.

- Dementia.

- Major opportunistic infection, current or past.

- Anemia (hemoglobin less than 9.5 g/dl).

Prior Medication:

Excluded within 1 month of study entry:

- Ribavirin or zidovudine (AZT) or other antivirals.

- Immunomodulating agents.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

016A

NCT ID:

NCT00002063

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Immune Tolerance
  • AIDS-Related Complex
  • Zidovudine
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS-Related Complex

Name

Location

Veterans Administration Med CtrWashington, District of Columbia  20422
Wadsworth Veterans Administration Med CtrLos Angeles, California  90073
San Francisco Veterans Administration Med CtrSan Francisco, California  94121
Walter Reed Army Med CtrWashington, District of Columbia  203075001
Dr Gordon DickinsonMiami, Florida  33136
Dr Gigi Diamond / New York Veterans AdministrationNew York, New York  10010
Veterans Affairs Med Ctr / Admin Only / Not For Patient CareDurham, North Carolina  27705
Houston Veterans Administration Med CtrHouston, Texas  77030