A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000907

Collaborator

(none)

Enrollment

Locations

2.1

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of stopping preventive therapy for DMAC in HIV-positive patients who (1) have been treated for DMAC for at least 12 months and are now free of any signs of DMAC for at least 16 weeks, and (2) have improved immune systems (CD4 cell counts greater than or equal to 100 cells/mm3) due to anti-HIV drug therapy.

DMAC is a serious and sometimes life-threatening infection that usually affects only HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) less than 50 cells/mm3. It is recommended that people who are likely to get DMAC be placed on preventive medications which help reduce the risk of infection. New anti-HIV combination drug therapies can increase CD4 cell counts and can reduce the level of HIV in the blood. When CD4 counts are increased, risk of DMAC infection is less. This study examines whether it is possible to stop preventive therapy for DMAC when CD4 counts are high without placing individuals at risk for getting DMAC again.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections

Detailed Description

A growing body of evidence suggests AIDS-related morbidity and mortality significantly decrease where potent antiretroviral therapies are used. HAART (highly active antiretroviral therapy) seems to significantly reduce the incidence of MAC. This study tests the validity of those observations.

Peripheral blood cultures and bone marrow (aspirate) samples from 50 eligible patients previously diagnosed with disseminated Mycobacterium avium complex (DMAC) are assessed for microbiologic sterilization of MAC at the time of study entry. If either bone marrow or blood cultures test positive for MAC, patients are discontinued from study. If cultures prove sterile, patients receive 6 weeks of treatment and then discontinue MAC therapy at Week 6 (entry into Step 2 of study). They are then monitored for clinical signs and symptoms of MAC recurrence and for the presence of mycobacteria in blood cultures. In cases of increased viral load during study, modification of antiretroviral therapy is allowed at the discretion of the patient's provider.

Study Design

Study Type:

Observational

Official Title:

A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have 2 CD4 cell counts greater than or equal to 100 cells/mm3 within 60 days and 14 days prior to entry. Measurements must be taken at least 24 hours apart.
Have been treated for DMAC with a drug regimen including at least 2 antimycobacterial drugs for at least 12 months, and have been free of symptoms for at least 16 weeks prior to study entry.
Have been on anti-HIV therapy for at least 16 weeks and have been on stable anti-HIV therapy for at least 8 weeks prior to study entry.
Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

Have any active infection (unless they have been on stable chronic suppressive therapy for at least 3 months).
Are pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
2	Willow Clinic	Menlo Park	California	United States	94025
3	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	921036325
4	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
5	San Francisco Gen Hosp	San Francisco	California	United States	941102859
6	Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium	San Jose	California	United States	951282699
7	San Mateo AIDS Program / Stanford Univ	Stanford	California	United States	943055107
8	Stanford Univ Med Ctr	Stanford	California	United States	943055107
9	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
10	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
11	Emory Univ	Atlanta	Georgia	United States	30308
12	Univ of Hawaii	Honolulu	Hawaii	United States	96816
13	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
14	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
15	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
16	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
17	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
18	Beth Israel Med Ctr	New York	New York	United States	10003
19	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
20	Mount Sinai Med Ctr	New York	New York	United States	10029
21	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
22	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
23	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania	United States	19104
24	Julio Arroyo	West Columbia	South Carolina	United States	29169