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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis


Phase 3
18 Years
N/A
Not Enrolling
Both
Cytomegalovirus Retinitis, HIV Infections

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Trial Information

Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Inclusion Criteria


Inclusion Criteria

Patient must have the following:

- AIDS as defined by CDC criteria.

- Retinitis as diagnosed by the study ophthalmologist.

- Performance status 0, 1, or 2.

- Ability to give informed consent and suitability of intravenous access for scheduled
blood tests.

- Patient may have Kaposi's sarcoma or basal skin cancer.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Active acute infection requiring treatment.

- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or
evidence of retinopathy.

- Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Patients with the following are excluded:

- Active acute infection requiring treatment.

- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or
evidence of retinopathy.

- Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Prior Medication:

Excluded:

- Granulocyte macrophage colony-stimulating factor (GM-CSF).

- Colony stimulating factor.

- Interleukin 3.

- Excluded within 7 days of study entry:

- Zidovudine (AZT).

- Trimethoprim / sulfamethoxazole (TMP / SMX).

- Pyrimethamine.

- Excluded within 30 days of study entry:

- Biologic response modifiers.

- Cytotoxic agents.

- Investigational agents.

Prior Treatment:

Excluded:

- Radiation therapy.

Required within 1 week of study entry:

- One or more doses of ganciclovir.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

005A

NCT ID:

NCT00002070

Start Date:

Completion Date:

Related Keywords:

  • Cytomegalovirus Retinitis
  • HIV Infections
  • Recombinant Proteins
  • Retinitis
  • AIDS-Related Opportunistic Infections
  • Neutropenia
  • Ganciclovir
  • Drug Therapy, Combination
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Cytomegalovirus Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Retinitis
  • Cytomegalovirus Retinitis

Name

Location

Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
UCLA CARE CtrLos Angeles, California  90095
Univ of PennsylvaniaPhiladelphia, Pennsylvania  19104
USC School of Medicine / Norris Cancer HospLos Angeles, California  90033
Children's Hosp of San FranciscoSan Francisco, California  94118
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Univ of Texas Southwestern Med Ctr of DallasDallas, Texas  75235
Pacific PresbyterianSan Francisco, California  94118
Gottlieb Med GroupSherman Oaks, California  91403
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med CollChicago, Illinois  60612
Cabrini Med CtrNew York, New York  10003
Dr Douglas DieterichNew York, New York  10016
Methodist HospHouston, Texas  77030
Infectious Disease Physicians IncAnnandale, Virginia  22203