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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000905
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 30, 2008
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date November 2, 1999
First Posted Date August 31, 2001
Last Update Posted Date July 30, 2008
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00000905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
Official Title Discontinuation of Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Immune Reconstitution by Potent Antiretroviral Therapy: Safety, Virology, and Immunology Profiles
Brief 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.

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.]

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Cytomegalovirus Retinitis
  • HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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 maintenance therapy for cytomegalovirus (CMV) retinitis and incidence of immune recovery uveitis following potent antiretroviral therapy. HIV Clin Trials. 2005 May-Jun;6(3):136-46.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
75
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00000905
Other Study ID Numbers ACTG 379
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Study Chair: Torriani F
Study Chair: Wohl D
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date June 2003