A Study of HIV-Disease Development in Aging

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006144
• Other study ID #: A5015
• Secondary ID: 10168ACTG A5015A
• Status: Completed
• Phase: Phase 2
• Start date: October 2000
• Est. completion date: April 2005

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Disease Progression
• HIV Infections

Intervention

Drug:
• Lopinavir/Ritonavir

• Emtricitabine

• Stavudine

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico-AIDS CRS	San Juan
United States	University of Colorado Hospital CRS	Aurora	Colorado
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts
United States	Bmc Actg Crs	Boston	Massachusetts
United States	Brigham and Women's Hosp. ACTG CRS	Boston	Massachusetts
United States	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts
United States	Unc Aids Crs	Chapel Hill	North Carolina
United States	Northwestern University CRS	Chicago	Illinois
United States	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois
United States	Case CRS	Cleveland	Ohio
United States	MetroHealth CRS	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic	Dallas	Texas
United States	Duke Univ. Med. Ctr. Adult CRS	Durham	North Carolina
United States	SSTAR, Family Healthcare Ctr.	Fall River	Massachusetts
United States	Univ. of Texas Medical Branch, ACTU	Galveston	Texas
United States	Queens Med. Ctr.	Honolulu	Hawaii
United States	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii
United States	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	Indiana Univ. School of Medicine, Wishard Memorial	Indianapolis	Indiana
United States	Methodist Hosp. of Indiana	Indianapolis	Indiana
United States	USC CRS	Los Angeles	California
United States	Univ. of Miami AIDS CRS	Miami	Florida
United States	University of Minnesota, ACTU	Minneapolis	Minnesota
United States	Vanderbilt Therapeutics CRS	Nashville	Tennessee
United States	Beth Israel Med. Ctr., ACTU	New York	New York
United States	Columbia Univ., HIV Prevention and Treatment Medical Ctr.	New York	New York
United States	Mt. Sinai Med. Ctr. A0404 CRS	New York	New York
United States	Mt.Sinai Med. Ctr. A1009 CRS	New York	New York
United States	NY Univ. HIV/AIDS CRS	New York	New York
United States	Stanford CRS	Palo Alto	California
United States	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania
United States	Philadelphia Veterans Admin. Med. Ctr. A6205 CRS	Philadelphia	Pennsylvania
United States	Rhode Island Hosp.	Providence	Rhode Island
United States	The Miriam Hosp. ACTG CRS	Providence	Rhode Island
United States	AIDS Care CRS	Rochester	New York
United States	Trillium Health ACTG CRS	Rochester	New York
United States	Univ. of Rochester ACTG CRS	Rochester	New York
United States	Washington U CRS	Saint Louis	Missouri
United States	Ucsf Aids Crs	San Francisco	California
United States	Santa Clara Valley Med. Ctr.	San Jose	California
United States	San Mateo County AIDS Program	San Mateo	California
United States	Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic	San Rafael	California
United States	University of Washington AIDS CRS	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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.

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