Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Efficacy of Elevated CD4 Cell Counts on CMV Retinitis
Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other
organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV
all have serious side effects. AIDS patients are prone to this infection because their
immune system produces a lower number of CD4+T lymphocytes, the type of blood cells that
fight viral infections.
Some new HIV medications strengthen the immune system. This study will investigate the
possibility that CMV patients on these HIV medications can develop immune systems strong
enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult
HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have
inactive CMV retinitis that is not immediately sight threatening. It is expected to last
approximately 2 years.
Each prospective participant will have a physical examination and complete eye examination,
including retina photographs, with the eye examination and retina photographs repeated 2
weeks later. If there is no evidence of active CMV retinitis, the participant will be
enrolled in the study, and CMV medication will be stopped. The participant will have
physical and eye examinations every 2 weeks for the first 3 months of the study, and every 3
weeks for the next 3 months. After 6 months, the frequency of the examinations will be 2-8
weeks, depending on the participant's CD4 count. After one year, a participant with a CD4
count remaining over 150 cells/microliter may return to the care of a local ophthalmologist
with HIV/CMV experience, revisiting the clinical center every 6 months. The participant's
CMV medication will be restarted when CMV retinitis becomes active, which will terminate
participation in the study.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Diagnosis of AIDS as defined by the Centers for Disease Control. Inactive, non-sight-threatening CMV retinitis. Non sight-threatening CMV retinitis is defined as CMV retinitis not within 1000 microns from the optic disc or 1000 microns from the fovea. Exception: patients with CMV retinitis within 1000 microns of the fovea or disc in only one eye, if visual acuity in that eye is worse than 20/400 without the use of eccentric fixation, and visual acuity in the other eye is 20/400 or better. CD4 T cell count greater than 150 cells per microliter. Patients must be able understand the nature of the study, agree to the provision, and understand and sign the informed consent form. Women and men age 18 or older are eligible for enrollment. Platelets greater than 25,000/microliter. Hemoglobin greater than 8.5 gms. Total neutrophil count greater than 750/mm(3). Karnofsky performance score greater than or equal to 60. Receiving systemic anti-CMV therapy. Receiving anti-HIV therapy. If the patient is receiving IL-2, at least one month from last infusion must elapse prior to assessment for eligibility. EXCLUSION CRITERIA: Intraocular sustained release ganciclovir implant in the eye for less than 9 months, or other organ involvement from CMV infection requiring use of systemic ganciclovir or foscarnet. CMV retinitis should not involve the retina solely anterior to the equator, or within 1000 microns from the optic disc, or within 1000 microns from the fovea. Exception: patients with lesions that have involved the fovea or disc and caused visual acuity worse than 20/400 without the use of eccentric fixation, may be included. Opacification of the cornea, lens, or vitreous in either eye that precludes examination of the fundus. Other retinal disease that could obscure the diagnosis of CMV retinitis, such as ocular toxoplasmosis. Significant psychiatric or emotional disorders that would impair patient understanding or participation in the trial. Life expectancy less than three months. Active CMV disease requiring systemic anti-CMV therapy. CMV retinitis first diagnosised with CD4 T-cell count greater than 150 cells per microliter. Need for medications with anti-CMV effect. Participation in conflicting clinical trial. Progression of CMV retinitis between screening and baseline examinations. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Eye Institute (NEI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Guarda LA, Luna MA, Smith JL Jr, Mansell PW, Gyorkey F, Roca AN. Acquired immune deficiency syndrome: postmortem findings. Am J Clin Pathol. 1984 May;81(5):549-57. — View Citation
Moskowitz L, Hensley GT, Chan JC, Adams K. Immediate causes of death in acquired immunodeficiency syndrome. Arch Pathol Lab Med. 1985 Aug;109(8):735-8. — View Citation
Palestine AG, Rodrigues MM, Macher AM, Chan CC, Lane HC, Fauci AS, Masur H, Longo D, Reichert CM, Steis R, et al. Ophthalmic involvement in acquired immunodeficiency syndrome. Ophthalmology. 1984 Sep;91(9):1092-9. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01968551 -
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
|
Phase 3 | |
Completed |
NCT02929069 -
A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
|
N/A | |
Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
Completed |
NCT02264509 -
Peripheral Arterial Insufficiency Associated With HIV/AIDS
|
N/A | |
Completed |
NCT02583464 -
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
|
Phase 1 | |
Completed |
NCT01440569 -
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
|
Phase 3 | |
Completed |
NCT00551330 -
Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED)
|
Phase 2 | |
Completed |
NCT00381212 -
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
|
Phase 1/Phase 2 | |
Completed |
NCT00097006 -
Retrovirus Epidemiology Donor Study-II (REDS-II)
|
N/A | |
Completed |
NCT00001409 -
Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
|
Phase 1 | |
Completed |
NCT00000590 -
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185)
|
Phase 3 | |
Completed |
NCT00000587 -
Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
|
Phase 2 | |
Completed |
NCT00005273 -
Pulmonary Complications of HIV Infection Study (PACS)
|
N/A | |
Completed |
NCT00005303 -
Effectiveness of AIDS Antibody Screening
|
N/A | |
Completed |
NCT00005301 -
Transfusion Safety Study (TSS)
|
N/A | |
Completed |
NCT00001650 -
Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients
|
N/A | |
Withdrawn |
NCT00243568 -
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
|
Phase 3 | |
Recruiting |
NCT05031819 -
Managing Hypertension Among People Living With HIV
|
N/A | |
Completed |
NCT00394004 -
Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials
|
N/A | |
Completed |
NCT01967940 -
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
|
Phase 3 |