A Study of HIV-Disease Development in Aging

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.]

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Robert Kalayjian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 7, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5015
  • 10168 (Registry Identifier: DAIDS ES)
  • ACTG A5015
  • AACTG A5015
  • Substudy ACTG A5016s
  • Substudy ACTG A5020s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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