HIV InfectionsPhase 2NCT00006144
A Study of HIV-Disease Development in Aging
A Phase 2 study testing Lopinavir/Ritonavir, Emtricitabine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/Ritonavir, Emtricitabine and Stavudine
- How many people
- 90 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Oct 2000to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States44 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Bmc Actg Crs
Boston, Massachusetts, 02118
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts
Unc Aids Crs
Chapel Hill, North Carolina, 275997215
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 441091998
The Ohio State University Medical Center
Columbus, Ohio, 432101228
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, 75235-9173
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555-0435
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California, 900331079
Univ. of Miami AIDS CRS
Miami, Florida, 331361013
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Vanderbilt Therapeutics CRS
Nashville, Tennessee
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, 10029
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York
Mt.Sinai Med. Ctr. A1009 CRS
New York, New York
Stanford CRS
Palo Alto, California, 943055107
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
Philadelphia, Pennsylvania, 19104
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906
Rhode Island Hosp.
Providence, Rhode Island
Trillium Health ACTG CRS
Rochester, New York, 14607
AIDS Care CRS
Rochester, New York, 14642
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsf Aids Crs
San Francisco, California, 941102859
Santa Clara Valley Med. Ctr.
San Jose, California, 951282699
San Mateo County AIDS Program
San Mateo, California, 943055107
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
San Rafael, California, 94903
University of Washington AIDS CRS
Seattle, Washington, 98104
Washington U CRS
St Louis, Missouri
About this study
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
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.
Read the 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.]
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Emtricitabine, Stavudine
- Keywords
- Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Cohort Studies, Ritonavir, Disease Progression, Antigens, CD, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Immunophenotyping, Deoxycytidine
- Medical subject headings
- HIV Infections, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/RitonavirDrug
EmtricitabineDrug
StavudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startOct 2000
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Kalayjian, Study chairMichael Lederman, Study chairRichard Pollard, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006144
- Sponsor's protocol ID
- A5015
- Other IDs
- 10168, ACTG A5015, AACTG A5015, Substudy ACTG A5016s, Substudy ACTG A5020s
- Status last verified
- Oct 2021
- First submitted
- 7 Aug 2000
- Last updated
- 1 Nov 2021
- Results posted
- No
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.
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.
PubMed 19008157
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00006144
- Acronym / sponsor ID
- A5015
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Cohort Studies, Ritonavir, Disease Progression, Antigens, CD, Reverse Transcriptase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- Apr 2005 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/Ritonavir | Drug | – |
| Emtricitabine | Drug | – |
| Stavudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- BackgroundKalayjian 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.
- Derived from this study: PubMed 19008157Tenorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kalayjian study chair
Michael Lederman study chair
Richard Pollard study chair
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lopinavir/Ritonavir, Emtricitabine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.