A Study of HIV-Disease Development in Aging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006144
First received: August 7, 2000
Last updated: November 6, 2013
Last verified: November 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 90
Study Start Date: October 2000
Study Completion Date: April 2005
Detailed Description:

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
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
  • Have a viral load of more than 2000 copies/ml within 60 days of study entry.
  • Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
  • Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
  • Have hepatitis within 30 days of study entry.
  • Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
  • Are receiving chemotherapy or radiation treatment.
  • Have taken antiretroviral drugs for more than 14 days.
  • Have received an HIV vaccine within 30 days of study.
  • Have a serious illness or infection within 14 days of the study.
  • Have other serious conditions that might interfere with study participation.
  • Have taken or plan to take certain other drugs that might affect the study results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006144

  Hide Study Locations
Locations
United States, California
USC CRS
Los Angeles, California, United States, 900331079
Stanford CRS
Palo Alto, California, United States, 943055107
Ucsf Aids Crs
San Francisco, California, United States, 941102859
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
San Mateo County AIDS Program
San Mateo, California, United States, 943055107
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
San Rafael, California, United States, 94903
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 331361013
United States, Hawaii
Queens Med. Ctr.
Honolulu, Hawaii, United States, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States, 46202
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States
United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, United States, 10029
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York, United States
Mt.Sinai Med. Ctr. A1009 CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
AIDS Care CRS
Rochester, New York, United States, 14642
Trillium Health ACTG CRS
Rochester, New York, United States, 14607
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 275997215
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106
MetroHealth CRS
Cleveland, Ohio, United States, 441091998
The Ohio State University Medical Center
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hosp.
Providence, Rhode Island, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
United States, Texas
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, United States, 75235-9173
Univ. of Texas Medical Branch, ACTU
Galveston,, Texas, United States, 77555-0435
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Robert Kalayjian
Study Chair: Michael Lederman
Study Chair: Richard Pollard
  More Information

Additional Information:
Publications:
Kalayjian R, Landay A, Pollard R, Pu M, Spritzer J, Tebas P, Gross B, Valcour V, Cu-Uvin S, Fiscus S, Fidel P, Wu A, Fox L, Stocker V, Lederman M, and AIDS Clinical Trials Group Protocol 5015. ACTG 5015: NaIve T-cell Reconstitution is Associated with Immune Activation. CROI 2004. Abstract 232.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006144     History of Changes
Other Study ID Numbers: A5015, 10168, ACTG A5015, AACTG A5015, Substudy ACTG A5016s, Substudy ACTG A5020s
Study First Received: August 7, 2000
Last Updated: November 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Cohort Studies
Ritonavir
Disease Progression
Antigens, CD
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Immunophenotyping
Deoxycytidine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Ritonavir
Lopinavir
Stavudine
Emtricitabine
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites

ClinicalTrials.gov processed this record on September 18, 2014