A Study of HIV-Disease Development in Aging

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ClinicalTrials.gov Identifier: NCT00006144

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : November 7, 2013

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Emtricitabine Drug: Stavudine	Phase 2

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 Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	90 participants
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
Study Start Date :	October 2000
Actual Study Completion Date :	April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006144

Show 45 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Study Chair:	Robert Kalayjian
Study Chair:	Michael Lederman
Study Chair:	Richard Pollard

More 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00006144 History of Changes
Other Study ID Numbers:	A5015 10168 ( Registry Identifier: DAIDS ES ) ACTG A5015 AACTG A5015 Substudy ACTG A5016s Substudy ACTG A5020s
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	November 7, 2013
Last Verified:	November 2013

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 Disease Progression Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Disease Attributes Pathologic Processes Slow Virus Diseases Ritonavir	Lopinavir Emtricitabine Stavudine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors

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