|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00006144 |
Purpose
The purpose of this study is to better understand the relationship between age and HIV disease progression.
This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Emtricitabine Drug: Stavudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| Official Title: | A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging |
| Estimated Enrollment: | 90 |
| Study Completion Date: | November 2005 |
Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.
Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 [AS PER AMENDMENT 06/04/02: 192] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 [AS PER AMENDMENT 06/04/02: Week 192]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s [AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.]
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| Marin County Specialty Clinic | |
| San Rafael, California, United States, 94903 | |
| Willow Clinic | |
| Menlo Park, California, United States, 94025 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Denver Dept of Health and Hosps | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Community Health Network Inc | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28232 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| MetroHealth Med Ctr | |
| Cleveland, Ohio, United States, 441091998 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia Veterans Administration Med Ctr | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Miriam Hosp / Brown Univ | |
| Providence, Rhode Island, United States, 02906 | |
| 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 | |
| Univ of Texas, Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Robert Kalayjian | |
| Study Chair: | Michael Lederman | |
| Study Chair: | Richard Pollard |
More Information
| Study ID Numbers: | ACTG A5015, Substudy ACTG A5016s, Substudy ACTG A5020s, AACTG A5015, DAIDS-ES ID 10168 |
| Study First Received: | August 7, 2000 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006144 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination Stavudine HIV Protease Inhibitors Cohort Studies Ritonavir Disease Progression |
Antigens, CD Reverse Transcriptase Inhibitors Anti-HIV Agents Immunophenotyping Deoxycytidine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Disease Attributes Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Disease Progression Infection Reverse Transcriptase Inhibitors Pathologic Processes Emtricitabine Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases |