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A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia


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

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Trial Information

A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Inclusion Criteria


Inclusion Criteria

Patients must have:

- Serum antibody to HIV with or without evidence of HIV antigenemia.

- White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions
separated by a minimum of 1 week.

- Qualifying indications for AZT therapy.

- Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Current or past history of malignancy including Kaposi's sarcoma.

- Excessive diarrhea or significant malabsorption.

- If patients have had > 10 percent weight loss within the past 3 months, they should
not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A <
75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or
other criteria.

- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of
opportunistic infection (IO).

- Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).

- Active OI requiring systemic treatment.

- Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Concurrent Medication:

Excluded within 4 weeks of study entry:

- Zidovudine (AZT).

- Other antiviral agent associated with leukopenia.

- Investigational drug.

- Immunomodulators.

- Interferon.

- Steroids.

- Excluded within 8 weeks of study entry:

- Ribavirin.

- Excluded within 4 months of study entry:

- Suramin.

Patients with the following are excluded:

- Current or past history of malignancy including Kaposi's sarcoma.

- Excessive diarrhea or significant malabsorption.

- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of
opportunistic infection (OI).

- Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).

- Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

- Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause
leukopenia.

Risk Behavior:

Excluded:

- Current drug or alcohol abusers.

- Unprotected sexual contact or other activities that may result in reinfection with
HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities
that may result in reinfection with HIV.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

067C

NCT ID:

NCT00002007

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Cytopenias
  • Leukopenia
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Leukopenia

Name

Location

Natl Cancer InstituteBethesda, Maryland  20892