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NCT00000905 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000905
Other study ID # ACTG 379
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated July 28, 2008

Study information
Verified date June 2003
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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receiving potent antiretroviral therapy for at least 8 weeks prior to entry [AS PER AMENDMENT 7/2/99: Group 2 has been withdrawn].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.]

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Northwestern Univ Med School Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Univ of Texas Galveston Galveston Texas
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States UCLA CARE Ctr Los Angeles California
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Willow Clinic Menlo Park California
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Chelsea Ctr New York New York
United States Cornell Univ Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of California / San Diego Treatment Ctr San Diego California
United States San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States San Francisco Gen Hosp San Francisco California
United States Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California
United States St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wohl DA, Kendall MA, Owens S, Holland G, Nokta M, Spector SA, Schrier R, Fiscus S, Davis M, Jacobson MA, Currier JS, Squires K, Alston-Smith B, Andersen J, Freeman WR, Higgins M, Torriani FJ; ACTG 379 Study Team. The safety of discontinuation of maintenan — View Citation

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