A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000905
First received: November 2, 1999
Last updated: July 28, 2008
Last verified: June 2003
  Purpose

The purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive patients with treated and healed CMV retinitis (eye disease) who have responded well to anti-HIV (antiretroviral) therapy.

The current therapies available to treat CMV retinitis are long-term therapies. However, it may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs.


Condition
Cytomegalovirus Retinitis
HIV Infections

Study Type: Observational
Official Title: Discontinuation of Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Immune Reconstitution by Potent Antiretroviral Therapy: Safety, Virology, and Immunology Profiles

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 75
Detailed Description:

This study proposes to assess the hypothesis that, in HIV-infected patients with treated and healed CMV retinitis, an increase in CD4+ T-cells after initiation of potent antiretroviral therapy is either directly related to, or a marker of, immunologic protection for CMV retinitis and is associated with a recovery in specific proliferation responses to CMV antigens.

In this study, 100 patients [AS PER AMENDMENT 7/2/99: 50 patients] with treated and healed, non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Patients are studied in 2 groups. Patients enrolled in Group 1 have CD4+ counts greater than 100 cells/mm3. Group 2 patients have CD4+ counts of 50-100 cells/mm3 and a minimum of a 2 log10 decrease in plasma HIV-1 RNA level or plasma HIV-1 RNA levels below the limit of detection while receiving potent antiretroviral therapy for at least 8 weeks prior to entry [AS PER AMENDMENT 7/2/99: Group 2 has been withdrawn]. An additional 25 patients who meet eligibility requirements but who choose to continue to receive maintenance therapy may also participate. All patients are followed to evaluate the relationship between reactivation or progression of CMV disease and changes in CMV DNA, HIV-1 RNA, and CD4+ cell counts. Patients are seen at Weeks 2, 4, 6 and 8, and every 4 weeks until study closure or for 12 months after the last subject is enrolled. [AS PER AMENDMENT 12/24/98: Patients with confirmed moderate to severe "immune recovery vitritis" should receive a 3-week course of systemic steroids (oral prednisone recommended). Moderate immune recovery vitritis is defined as symptomatic decrease in visual acuity of 2 or more Snellen lines along with, in the absence of active CMV disease, either 2+ or greater vitreous haze as defined by Nussenblatt et al., or cystoid macular edema.] [AS PER AMENDMENT 7/2/99: During the course of the study in patients with confirmed cystoid macular edema and a concomitant reduction in visual activity below 20/40, both attributable to immune recovery vitritis/uveitis only, a 21-day course of oral prednisone is recommended. This initial course of steroids helps to determine whether there is an improvement in vision or a decrease in macular edema. Long-term management of immune recovery vitritis/uveitis may include intraocular injection of steroids. Ophthalmoscopic examinations and laboratory tests are performed as per protocol.]

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a CD4 count greater than 100 cells/mm3.
  • Have healed CMV retinitis after receiving anti-CMV therapy for at least 8 weeks within 3 months prior to study entry.
  • Have taken antiretroviral therapy for at least 8 weeks prior to study entry; combination therapy must include at least 2 of the following: protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Have a life expectancy of at least 6 months.
  • Are at least 13 years old (need consent if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

  • Have any unstable or severe medical conditions that would keep you from completing the study.
  • Require chemotherapy or radiation therapy.
  • Have a history of certain eye disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000905

Locations
United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Willow Clinic
Menlo Park, California, United States, 94025
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, New York
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Cornell Univ Med Ctr
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
Chelsea Ctr
New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Sponsors and Collaborators
Investigators
Study Chair: Torriani F
Study Chair: Wohl D
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000905     History of Changes
Other Study ID Numbers: ACTG 379
Study First Received: November 2, 1999
Last Updated: July 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immunity, Cellular
Disease Progression
Cytomegalovirus Retinitis
DNA, Viral
Prognosis

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
HIV Infections
Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retinal Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014