Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

Sponsor

AIDS Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00001137

Collaborator

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

5,982

Enrollment

Locations

166

Duration (Months)

77.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections

Detailed Description

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Study Design

Study Type:

Observational

Actual Enrollment :

5982 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Outcome Measures

Primary Outcome Measures

Successive suppressed viral load measures [Measured 144 weeks after randomization]
Genotypic or phenotypic resistance [Measured at baseline and study completion]
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater [Measured throughout]
Absolute number and percentage of CD4 and CD8 T cells [Measured 144 weeks after randomization]
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells [Measured 144 weeks after randomization]
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells [Measured 144 weeks after randomization]
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells [Measured 144 weeks after randomization]

Secondary Outcome Measures

HIV-1 latency or replication in tissue or cellular reservoirs [Measured at baseline, Week 16, Week 48, and study completion]
Syncytium and non-syncytium inducing (SI/NSI) phenotype [Measured at baseline, Week 16, Week 48, and study completion]
Metabolic and neurologic complications [Measured at baseline, Week 16, Week 48, and study completion]
Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV [Measured 144 weeks after randomization]
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) [Measured at baseline, Week 16, and study completion]
Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities [Measured at baseline, Week 48, and study completion]
Quality of life scores [Measured at baseline, Week 48, and study completion]
Subject-reported patterns of adherence [Measured at baseline, Week 48, and study completion]
Estimated inpatient, outpatient, and total costs [Measured at study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

HIV-1 infected
Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
Willing to provide consent for the release and use of clinical data from the parent study
Life expectancy of at least 24 weeks
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

Active alcohol or drug abuse that may interfere with the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Kaiser Permanente LAMC	Los Angeles	California	United States	90027
3	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
4	UCLA CARE Ctr	Los Angeles	California	United States	90095
5	Willow Clinic	Menlo Park	California	United States	94025
6	UC Davis Med Ctr	Sacramento	California	United States	95814
7	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	921036325
8	Univ of California, San Francisco/San Francisco General Hosp	San Francisco	California	United States	94110
9	Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium	San Jose	California	United States	951282699
10	Marin County Specialty Clinic	San Rafael	California	United States	94903
11	San Mateo AIDS Program / Stanford Univ	Stanford	California	United States	943055107
12	Stanford Univ Med Ctr	Stanford	California	United States	943055107
13	Harbor UCLA Med Ctr	Torrance	California	United States	90502
14	Denver Public Health CRS	Denver	Colorado	United States	80204
15	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
16	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
17	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
18	Emory Univ	Atlanta	Georgia	United States	30308
19	Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr	Atlanta	Georgia	United States	303652225
20	Univ of Hawaii	Honolulu	Hawaii	United States	96816
21	Tripler Army Med Ctr	Tripler AMC	Hawaii	United States	96859
22	Northwestern Univ Med School	Chicago	Illinois	United States	60611
23	Cook County Hosp	Chicago	Illinois	United States	60612
24	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
25	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
26	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
27	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana	United States	46202
28	Univ of Iowa Hosp and Clinic	Iowa City	Iowa	United States	52242
29	Tulane Med Ctr Hosp	New Orleans	Louisiana	United States	70112
30	IHV Baltimore Treatment CRS	Baltimore	Maryland	United States	21201
31	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
32	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts	United States	02114
33	Brigham and Women's Hosp	Boston	Massachusetts	United States	02115
34	Boston Med Ctr	Boston	Massachusetts	United States	02118
35	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215
36	Wayne State Univ. CRS	Detroit	Michigan	United States	48201
37	Hennepin County Medical Clinic	Minneapolis	Minnesota	United States	55415
38	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
39	St Louis Regional Hosp / St Louis Regional Med Ctr	St Louis	Missouri	United States	63112
40	Univ of Nebraska Med Ctr	Omaha	Nebraska	United States	681985130
41	Cooper Univ. Hosp. CRS	Camden	New Jersey	United States	08103
42	New Jersey Medical School- Adult Clinical Research Ctr. CRS	Newark	New Jersey	United States	07103
43	Bronx-Lebanon Hosp. Ctr. CRS	Bronx	New York	United States	10457
44	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
45	Beth Israel Med Ctr	New York	New York	United States	10003
46	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
47	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016
48	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ	New York	New York	United States	10021
49	Chelsea Ctr	New York	New York	United States	10021
50	Cornell Univ Med Ctr	New York	New York	United States	10021
51	Mount Sinai Med Ctr	New York	New York	United States	10029
52	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
53	AIDS Care CRS	Rochester,	New York	United States	14607
54	Community Health Network Inc	Rochester	New York	United States	14642
55	Univ of Rochester Medical Center	Rochester	New York	United States	14642
56	Wake County Department of Health	Chapel Hill	North Carolina	United States	27514
57	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
58	Carolinas Med Ctr	Charlotte	North Carolina	United States	28203
59	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
60	Moses H Cone Memorial Hosp	Greensboro	North Carolina	United States	27401
61	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
62	Cleveland Clinic	Cleveland	Ohio	United States	44106-5083
63	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
64	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
65	The Research & Education Group-Portland CRS	Portland	Oregon	United States	97210
66	Presbyterian Medical Center - Univ. of PA	Norristown	Pennsylvania	United States	19401
67	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania	United States	19104
68	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
69	Julio Arroyo	West Columbia	South Carolina	United States	29169
70	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37203
71	Peabody Health Center CRS	Dallas	Texas	United States	75215
72	Univ of Texas, Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75390
73	Houston AIDS Research Team CRS	Houston	Texas	United States	77030
74	Virginia Commonwealth Univ. Medical Ctr. CRS	Richmond	Virginia	United States	23219
75	Univ of Washington	Seattle	Washington	United States	98104
76	Puerto Rico-AIDS CRS	San Juan,		Puerto Rico	00935
77	Univ of Puerto Rico	San Juan		Puerto Rico	009365067

Sponsors and Collaborators

AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Constance A. Benson, MD, Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair: Ann C. Collier, MD, University of Washington