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HIV InfectionsNCT00000932

A Study of the Long-Term Outcomes of HIV-Positive Patients

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all. Anti-HIV treatment has been successful in slowing disease progression in many patients. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
How many people
3,669 participants
Where
91 sitesUnited States
Study dates
Mar 1999to Sep 2006
Phase
Observational
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

Study population: HIV infected individuals

Who may be able to join

  • Patients may be eligible for this study if they:
  • Are 13 years of age or older (consent of parent or guardian required if under the age of 18).
  • Are HIV-positive.
  • Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study.

Who cannot join

None listed.

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

United States91 sites

  • Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS

    Baton Rouge, Louisiana, 70805

  • James Osterberger, MD (Private Med. Practice) CRS

    Baton Rouge, Louisiana, 70808-4390

  • CRI-Boston CRS

    Boston, Massachusetts, 02115

  • Beacon Clinic at Boulder CRS

    Boulder, Colorado, 80501-4507

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 08103

  • Klein & Slotten Medical Associates CRS

    Chicago, Illinois, 60610

  • Cook County Hosp. CORE Ctr. INSIGHT CRS

    Chicago, Illinois, 60612

  • Cook County Hosp. CORE Ctr.

    Chicago, Illinois, 60612

  • Univ. of Illinois Family Ctr. for Infectious Disease CRS

    Chicago, Illinois, 60612

  • Lakeshore Infectious Disease Associates CRS

    Chicago, Illinois, 60657

  • North Side Family Medicine CRS

    Chicago, Illinois, 60657

  • Northwestern Memorial Physicians Group CRS

    Chicago, Illinois, 60657

  • Triad Health Practice/Ill. Masonic Med. Ctr. CRS

    Chicago, Illinois, 60657

  • Denver Infectious Diseases Consultants CRS

    Denver, Colorado, 80204-4507

  • Kaiser Permanente of Denver CRS

    Denver, Colorado, 80204-4507

  • Univ. of Colorado Health Science Ctr. CRS

    Denver, Colorado, 80204-4507

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Eastside Family Health Ctr. CRS

    Denver, Colorado, 80205

  • APEX Family Medicine CRS

    Denver, Colorado, 80206

  • South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS

    Denver, Colorado, 80218

  • Denver Public Health CRS - INSIGHT

    Denver, Colorado

  • Harper Hosp., Detroit CRS

    Detroit, Michigan, 48201

  • Wayne State Univ. INSIGHT CRS

    Detroit, Michigan, 48201

  • Henry Ford Hosp. CRS

    Detroit, Michigan, 48202

  • Detroit Community Health Connection, Inc. CRS

    Detroit, Michigan, 48215

  • Detroit Community Health Connection-2 CRS

    Detroit, Michigan, 48215

  • Univ. of Connecticut Health Ctr. CRS

    Farmington, Connecticut, 06030

  • ID Care Inc. - Hillsborough CRS

    Hillsborough, New Jersey, 08844

  • Legacy Community Health Services, Inc. CRS

    Houston, Texas, 77006

  • Baylor College of Medicine, Thomas St. Clinic CRS

    Houston, Texas, 77030

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • Michael E. DeBakey VAMC CRS

    Houston, Texas, 77030

  • Thomas Street Clinic CRS

    Houston, Texas, 77030

  • Hanover Med. Park (Mechanicsville, VA) CRS

    Mechanicsville, Virginia, 23116

  • Dr. M. Estes Med. Practice CRS

    Mill Valley, California, 94941-3013

  • Jersey Shore Univ. Med. Ctr. CRS

    Neptune City, New Jersey, 07754

  • Yale Univ. School of Medicine, NE ProACT - New Haven CRS

    New Haven, Connecticut, 06510

  • Hosp. of St. Raphael CRS

    New Haven, Connecticut, 06511

  • Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

    New Orleans, Louisiana, 70112

  • Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

    New Orleans, Louisiana, 70112

  • Memorial Med. Ctr., Hematology-Oncology Services CRS

    New Orleans, Louisiana, 70115

  • New Orleans VAMC CRS

    New Orleans, Louisiana, 70146

  • St. Vincent Hosp. & Med. Ctr. CRS

    New York, New York, 10011

  • HHC Methadone Maintenance, Treatment Program Unit 1 CRS

    New York, New York, 10026

  • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

    New York, New York, 10037-1802

  • Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

    Newark, New Jersey, 07103

  • New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

    Newark, New Jersey, 07103

  • Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS

    Norfolk, Virginia, 23507

  • Dr. Robert Scott Med. Practice CRS

    Oakland, California, 94609

  • East Bay AIDS Ctr. CRS

    Oakland, California, 94609

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

    Paterson, New Jersey, 07503

  • Raritan Bay Med. Ctr., Perth Amboy Division CRS

    Perth Amboy, New Jersey, 08861

  • Petersburg Health Care Alliance CRS

    Petersburg, Virginia, 23803

  • Philadelphia FIGHT - Dr. Jay Kostman CRS

    Philadelphia, Pennsylvania, 19107

  • Temple Univ. School of Medicine CRS

    Philadelphia, Pennsylvania, 19140

  • Multnomah County Health Dept., HIV Health Services Ctr. CRS

    Portland, Oregon, 97204

  • Legacy Clinic Good Samaritan CRS

    Portland, Oregon, 97210

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97210

  • Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

    Portland, Oregon, 97213

  • Kaiser Immune Deficiency Clinic of Portland CRS

    Portland, Oregon, 97227

  • Legacy Clinic Emanuel CRS

    Portland, Oregon, 97227

  • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

    Portland, Oregon, 97239

  • ID Care - Randolph CRS

    Randolph Township, New Jersey, 07869

  • CrossOver Health Ctr. CRS

    Richmond, Virginia, 23224

  • South Richmond Health Care Ctr. CRS

    Richmond, Virginia, 23224

  • Hunter Holmes McGuire VAMC CRS

    Richmond, Virginia, 23249

  • VCU Health Systems, Infectious Disease Clinic CRS

    Richmond, Virginia, 23298

  • Virginia Commonwealth Univ. Medical Ctr. CRS

    Richmond, Virginia, 23298

  • Salem Hosp. CRS

    Salem, Oregon, 97301

  • Kaiser Permanente Lancaster Clinic CRS

    Salem, Oregon, 97305

  • Dr. Shawn Hassler Med. Practice CRS

    San Francisco, California, 94102

  • Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

    San Francisco, California, 94110

  • Dr. Virginia Cafaro Med. Practice CRS

    San Francisco, California, 94114-1010

  • Dr. William Owen Med. Practice CRS

    San Francisco, California, 94114-1010

  • Castro-Mission Health Ctr. CRS

    San Francisco, California, 94114

  • Dr. Martin Mass Med. Practice CRS

    San Francisco, California, 94114

  • St. Mary's Med. Ctr. of San Francisco CRS

    San Francisco, California, 94117

  • San Francisco VAMC, Infectious Diseases Clinic CRS

    San Francisco, California, 94121

  • UCSF PHP, Gen. Internal Medicine Practice CRS

    San Francisco, California, 94143

  • CRI-Springfield CRS

    Springfield, Massachusetts, 01107

  • Bronx Prevention Center CRS

    The Bronx, New York, 10452

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

  • Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

    The Bronx, New York, 10461

  • Jacobi Med. Ctr.

    The Bronx, New York, 10461

  • Montefiore Med. Ctr., AIDS Ctr. CRS

    The Bronx, New York, 10467

  • Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

    Union, New Jersey, 07083

  • The Early Intervention Program at Kennedy Hosp. CRS

    Voorhees Township, New Jersey, 08043

  • Dotson & Hodge Med. Group, L.L.C. CRS

    Washington D.C., District of Columbia, 20003

  • Dr. Timothy A. Price Med. Practice CRS

    Washington D.C., District of Columbia, 20036

  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

    Washington D.C., District of Columbia, 20422

  • Western Infectious Disease Consultants CRS

    Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals

The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all.

Anti-HIV treatment has been successful in slowing disease progression in many patients. However, there are still questions regarding the best way to use anti-HIV drugs. This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment.

Read the detailed description

Highly active antiretroviral therapy (HAART) often results in short-term benefits for people with HIV in terms of reduced plasma viral levels and increased CD4 cell counts. When used at an early stage of HIV disease, however, the clinical benefit of HAART is uncertain. Many questions still remain regarding the optimal use of antiretroviral therapies, such as the timing of initial antiretroviral therapy and the composition of the best combination regimen to use initially or after virologic failure. Randomized trials of different starting antiretroviral regimens (e.g., FIRST [CPCRA 058]), different regimens after initial virologic failure (e.g., PIP [CPCRA 057]), and different management strategies for HIV infection (e.g., bis-POM [CPCRA 039], NvR [CPCRA 042], GART [CPCRA 046], and IL-2 VL/Dose [CPCRA 059] are being conducted by the CPCRA. [AS PER AMENDMENT 2/28/01: The MDR-HIV (CPCRA 064) protocol is now included as an example of a different management strategy for HIV infection, whereas the bis-POM (CPCRA 039) protocol is no longer included.] This study provides a mechanism for long-term monitoring of patients enrolled in these trials as well as antiretroviral-naive patients who are either starting treatment or electing to defer treatment.

Patients are divided into 3 groups. Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study (see Purpose for CPCRA trials which qualify). Group B consists of patients previously enrolled in but not currently being followed in a qualifying study. Group C consists of antiretroviral-naive patients not enrolling in a qualifying study (i.e., patients starting treatment outside the FIRST study or patients deferring treatment). Patients in Group A undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled. Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 months. Patients are followed for at least 5 years. [AS PER AMENDMENT 2/28/01: Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST (CPCRA 058) protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved, HIV-related research. Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release (every 4 months) of their medical records from their new health care provider to the CPCRA.]

Conditions
HIV Infections
Keywords
Prospective Studies, HIV-1, Drug Therapy, Combination, Drug Resistance, Microbial, CD4 Lymphocyte Count, Disease Progression, Treatment Outcome, Genotype, Anti-HIV Agents, Viral Load
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.

Study groups in NCT00000932
Study groupRoleWhat they receive
AParticipants currently enrolled in or currently being followed in an ongoing qualifying study. Qualifying studies can be found in the protocol.
BParticipants previously enrolled in but not currently being followed in a qualifying study. Qualifying studies can be found in the protocol.
CAntiretroviral-naive participants not enrolling in a qualifying study (i.e., patients starting treatment outside the first study or patients deferring treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical disease progression or death

    Measured: Throughout study

Secondary outcomes (5)

  1. Survival

    Measured: Throughout study

  2. Selected metabolic, hepatic, and cardiovascular conditions

    Measured: Throughout study

  3. Changes in viral load

    Measured: Throughout study

  4. Changes in CD4 count

    Measured: Throughout study

  5. Changes in HIV treatment methods

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study startMar 1999
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000932
Sponsor's protocol ID
CPCRA 060
Other IDs
10110
Status last verified
Apr 2014
First submitted
2 Nov 1999
Last updated
15 Apr 2014
Results posted
No

Publications

  • Goetz MB, Leduc R, Kostman JR, Labriola AM, Lie Y, Weidler J, Coakley E, Bates M, Luskin-Hawk R; Long-Term Monitoring Study (CPCRA 060) and Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Relationship between HIV coreceptor tropism and disease progression in persons with untreated chronic HIV infection. J Acquir Immune Defic Syndr. 2009 Mar 1;50(3):259-66. doi: 10.1097/QAI.0b013e3181989a8b.

    PubMed 19194318

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in United States.

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 4 inclusion and 0 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 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. 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.

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.

What does the primary outcome measure?

Clinical disease progression or death (time frame: Throughout study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000932, which also lists 1 linked publication.

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 15 Apr 2014.

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