Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
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To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Sargramostim Drug: Ganciclovir |
Phase 3 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
USC School of Medicine / Norris Cancer Hosp | |
Los Angeles, California, United States, 90033 | |
Children's Hosp of San Francisco | |
San Francisco, California, United States, 94118 | |
Pacific Presbyterian | |
San Francisco, California, United States, 94118 | |
Gottlieb Med Group | |
Sherman Oaks, California, United States, 91403 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
Cabrini Med Ctr | |
New York, New York, United States, 10003 | |
Dr Douglas Dieterich | |
New York, New York, United States, 10016 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
Methodist Hosp | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 |
No publications provided
ClinicalTrials.gov Identifier: | NCT00002070 History of Changes |
Other Study ID Numbers: | 005A, C88-059 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins Retinitis AIDS-Related Opportunistic Infections Neutropenia Ganciclovir |
Drug Therapy, Combination Granulocyte-Macrophage Colony-Stimulating Factor Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013