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

  Show 45 Study Locations
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
HIV Protease Inhibitors
Ritonavir
Lopinavir
Stavudine
Reverse Transcriptase Inhibitors
Emtricitabine
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 August 18, 2014