NCT00000932

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,669

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1999

Longer than P75 for all trials

Geographic Reach
1 country

91 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

7.5 years

First QC Date

November 2, 1999

Last Update Submit

April 14, 2014

Conditions

Keywords

Prospective StudiesHIV-1Drug Therapy, CombinationDrug Resistance, MicrobialCD4 Lymphocyte CountDisease ProgressionTreatment OutcomeGenotypeAnti-HIV AgentsViral Load

Outcome Measures

Primary Outcomes (1)

  • Clinical disease progression or death

    Throughout study

Secondary Outcomes (5)

  • Survival

    Throughout study

  • Selected metabolic, hepatic, and cardiovascular conditions

    Throughout study

  • Changes in viral load

    Throughout study

  • Changes in CD4 count

    Throughout study

  • Changes in HIV treatment methods

    Throughout study

Study Arms (3)

A

Participants currently enrolled in or currently being followed in an ongoing qualifying study. Qualifying studies can be found in the protocol.

B

Participants previously enrolled in but not currently being followed in a qualifying study. Qualifying studies can be found in the protocol.

C

Antiretroviral-naive participants not enrolling in a qualifying study (i.e., patients starting treatment outside the first study or patients deferring treatment)

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV infected individuals

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (91)

Dr. M. Estes Med. Practice CRS

Mill Valley, California, 94941-3013, United States

Location

Dr. Robert Scott Med. Practice CRS

Oakland, California, 94609, United States

Location

East Bay AIDS Ctr. CRS

Oakland, California, 94609, United States

Location

Dr. Shawn Hassler Med. Practice CRS

San Francisco, California, 94102, United States

Location

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

San Francisco, California, 94110, United States

Location

Dr. Virginia Cafaro Med. Practice CRS

San Francisco, California, 94114-1010, United States

Location

Dr. William Owen Med. Practice CRS

San Francisco, California, 94114-1010, United States

Location

Castro-Mission Health Ctr. CRS

San Francisco, California, 94114, United States

Location

Dr. Martin Mass Med. Practice CRS

San Francisco, California, 94114, United States

Location

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

San Francisco, California, 94117, United States

Location

San Francisco VAMC, Infectious Diseases Clinic CRS

San Francisco, California, 94121, United States

Location

UCSF PHP, Gen. Internal Medicine Practice CRS

San Francisco, California, 94143, United States

Location

Beacon Clinic at Boulder CRS

Boulder, Colorado, 80501-4507, United States

Location

Denver Infectious Diseases Consultants CRS

Denver, Colorado, 80204-4507, United States

Location

Kaiser Permanente of Denver CRS

Denver, Colorado, 80204-4507, United States

Location

Univ. of Colorado Health Science Ctr. CRS

Denver, Colorado, 80204-4507, United States

Location

Denver Public Health CRS

Denver, Colorado, 80204, United States

Location

Eastside Family Health Ctr. CRS

Denver, Colorado, 80205, United States

Location

APEX Family Medicine CRS

Denver, Colorado, 80206, United States

Location

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

Denver, Colorado, 80218, United States

Location

Denver Public Health CRS - INSIGHT

Denver, Colorado, United States

Location

Western Infectious Disease Consultants CRS

Wheat Ridge, Colorado, 80033, United States

Location

Univ. of Connecticut Health Ctr. CRS

Farmington, Connecticut, 06030, United States

Location

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

New Haven, Connecticut, 06510, United States

Location

Hosp. of St. Raphael CRS

New Haven, Connecticut, 06511, United States

Location

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

Washington D.C., District of Columbia, 20003, United States

Location

Dr. Timothy A. Price Med. Practice CRS

Washington D.C., District of Columbia, 20036, United States

Location

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

Washington D.C., District of Columbia, 20422, United States

Location

Klein & Slotten Medical Associates CRS

Chicago, Illinois, 60610, United States

Location

Cook County Hosp. CORE Ctr. INSIGHT CRS

Chicago, Illinois, 60612, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Univ. of Illinois Family Ctr. for Infectious Disease CRS

Chicago, Illinois, 60612, United States

Location

Lakeshore Infectious Disease Associates CRS

Chicago, Illinois, 60657, United States

Location

North Side Family Medicine CRS

Chicago, Illinois, 60657, United States

Location

Northwestern Memorial Physicians Group CRS

Chicago, Illinois, 60657, United States

Location

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

Chicago, Illinois, 60657, United States

Location

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

Baton Rouge, Louisiana, 70805, United States

Location

James Osterberger, MD (Private Med. Practice) CRS

Baton Rouge, Louisiana, 70808-4390, United States

Location

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

New Orleans, Louisiana, 70112, United States

Location

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

New Orleans, Louisiana, 70112, United States

Location

Memorial Med. Ctr., Hematology-Oncology Services CRS

New Orleans, Louisiana, 70115, United States

Location

New Orleans VAMC CRS

New Orleans, Louisiana, 70146, United States

Location

CRI-Boston CRS

Boston, Massachusetts, 02115, United States

Location

CRI-Springfield CRS

Springfield, Massachusetts, 01107, United States

Location

Harper Hosp., Detroit CRS

Detroit, Michigan, 48201, United States

Location

Wayne State Univ. INSIGHT CRS

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp. CRS

Detroit, Michigan, 48202, United States

Location

Detroit Community Health Connection, Inc. CRS

Detroit, Michigan, 48215, United States

Location

Detroit Community Health Connection-2 CRS

Detroit, Michigan, 48215, United States

Location

Cooper Univ. Hosp. CRS

Camden, New Jersey, 08103, United States

Location

ID Care Inc. - Hillsborough CRS

Hillsborough, New Jersey, 08844, United States

Location

Jersey Shore Univ. Med. Ctr. CRS

Neptune City, New Jersey, 07754, United States

Location

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

Newark, New Jersey, 07103, United States

Location

New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

Newark, New Jersey, 07103, United States

Location

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

Paterson, New Jersey, 07503, United States

Location

Raritan Bay Med. Ctr., Perth Amboy Division CRS

Perth Amboy, New Jersey, 08861, United States

Location

ID Care - Randolph CRS

Randolph Township, New Jersey, 07869, United States

Location

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

Union, New Jersey, 07083, United States

Location

The Early Intervention Program at Kennedy Hosp. CRS

Voorhees Township, New Jersey, 08043, United States

Location

St. Vincent Hosp. & Med. Ctr. CRS

New York, New York, 10011, United States

Location

HHC Methadone Maintenance, Treatment Program Unit 1 CRS

New York, New York, 10026, United States

Location

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

New York, New York, 10037-1802, United States

Location

Bronx Prevention Center CRS

The Bronx, New York, 10452, United States

Location

Bronx-Lebanon Hosp. Ctr. CRS

The Bronx, New York, 10457, United States

Location

Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

The Bronx, New York, 10461, United States

Location

Jacobi Med. Ctr.

The Bronx, New York, 10461, United States

Location

Montefiore Med. Ctr., AIDS Ctr. CRS

The Bronx, New York, 10467, United States

Location

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

Portland, Oregon, 97204, United States

Location

Legacy Clinic Good Samaritan CRS

Portland, Oregon, 97210, United States

Location

The Research & Education Group-Portland CRS

Portland, Oregon, 97210, United States

Location

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

Portland, Oregon, 97213, United States

Location

Kaiser Immune Deficiency Clinic of Portland CRS

Portland, Oregon, 97227, United States

Location

Legacy Clinic Emanuel CRS

Portland, Oregon, 97227, United States

Location

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

Portland, Oregon, 97239, United States

Location

Salem Hosp. CRS

Salem, Oregon, 97301, United States

Location

Kaiser Permanente Lancaster Clinic CRS

Salem, Oregon, 97305, United States

Location

Philadelphia FIGHT - Dr. Jay Kostman CRS

Philadelphia, Pennsylvania, 19107, United States

Location

Temple Univ. School of Medicine CRS

Philadelphia, Pennsylvania, 19140, United States

Location

Legacy Community Health Services, Inc. CRS

Houston, Texas, 77006, United States

Location

Baylor College of Medicine, Thomas St. Clinic CRS

Houston, Texas, 77030, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VAMC CRS

Houston, Texas, 77030, United States

Location

Thomas Street Clinic CRS

Houston, Texas, 77030, United States

Location

Hanover Med. Park (Mechanicsville, VA) CRS

Mechanicsville, Virginia, 23116, United States

Location

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

Norfolk, Virginia, 23507, United States

Location

Petersburg Health Care Alliance CRS

Petersburg, Virginia, 23803, United States

Location

CrossOver Health Ctr. CRS

Richmond, Virginia, 23224, United States

Location

South Richmond Health Care Ctr. CRS

Richmond, Virginia, 23224, United States

Location

Hunter Holmes McGuire VAMC CRS

Richmond, Virginia, 23249, United States

Location

VCU Health Systems, Infectious Disease Clinic CRS

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth Univ. Medical Ctr. CRS

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV InfectionsDisease Progression

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jay Kostman

    STUDY CHAIR
  • Roberta Luskin-Hawk

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

March 1, 1999

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations