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A Study of HIV-Disease Development in Aging

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Emtricitabine
Stavudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Cohort Studies, Ritonavir, Disease Progression, Antigens, CD, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Immunophenotyping, Deoxycytidine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • Stanford CRS
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
  • University of Colorado Hospital CRS
  • Univ. of Miami AIDS CRS
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Methodist Hosp. of Indiana
  • Johns Hopkins Adult AIDS CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • Brigham and Women's Hosp. ACTG CRS
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • SSTAR, Family Healthcare Ctr.
  • University of Minnesota, ACTU
  • Washington U CRS
  • Beth Israel Med. Ctr., ACTU
  • NY Univ. HIV/AIDS CRS
  • Mt. Sinai Med. Ctr. A0404 CRS
  • Columbia Univ., HIV Prevention and Treatment Medical Ctr.
  • Mt.Sinai Med. Ctr. A1009 CRS
  • Trillium Health ACTG CRS
  • AIDS Care CRS
  • Univ. of Rochester ACTG CRS
  • Unc Aids Crs
  • Duke Univ. Med. Ctr. Adult CRS
  • Case CRS
  • MetroHealth CRS
  • The Ohio State University Medical Center
  • Hosp. of the Univ. of Pennsylvania CRS
  • Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
  • The Miriam Hosp. ACTG CRS
  • Rhode Island Hosp.
  • Vanderbilt Therapeutics CRS
  • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
  • Univ. of Texas Medical Branch, ACTU
  • University of Washington AIDS CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 7, 2000
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00006144
Brief Title
A Study of HIV-Disease Development in Aging
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Cohort Studies, Ritonavir, Disease Progression, Antigens, CD, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Immunophenotyping, Deoxycytidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Emtricitabine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kalayjian
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Lederman
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Pollard
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Brigham and Women's Hosp. ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
SSTAR, Family Healthcare Ctr.
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Beth Israel Med. Ctr., ACTU
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai Med. Ctr. A0404 CRS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
City
New York
State/Province
New York
Country
United States
Facility Name
Mt.Sinai Med. Ctr. A1009 CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Trillium Health ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
AIDS Care CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
441091998
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Miriam Hosp. ACTG CRS
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Rhode Island Hosp.
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Vanderbilt Therapeutics CRS
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9173
Country
United States
Facility Name
Univ. of Texas Medical Branch, ACTU
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0435
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
19008157
Citation
Tenorio AR, Spritzler J, Martinson J, Gichinga CN, Pollard RB, Lederman MM, Kalayjian RC, Landay AL. The effect of aging on T-regulatory cell frequency in HIV infection. Clin Immunol. 2009 Mar;130(3):298-303. doi: 10.1016/j.clim.2008.10.001. Epub 2008 Nov 12.
Results Reference
derived

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A Study of HIV-Disease Development in Aging

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