A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons
2 other identifiers
interventional
1,710
1 country
17
Brief Summary
The purpose of this study is to determine whether it is better to start an anti-HIV regimen containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment regimen is best as a first treatment for HIV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
17 active sites
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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedApril 17, 2014
April 1, 2014
November 2, 1999
April 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in CD4 count from baseline to the average of all readings obtained at the regular follow-up visits beginning at Month 32
time to disease progression, death, or CD4 count less than 200 cells/mm3 at the 4 Month visit for those patients with a baseline CD4 cell count of more than or equal to 200 cells/mm3
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- Agree to practice abstinence or to use barrier methods of birth control during the study
- Are at least 13 years old or have signed informed consent from legal guardian for patients between the ages of 13 and 18
You may not qualify if:
- Have ever taken any anti-HIV drugs
- Are unable to complete the study for any reason
- Pregnancy
- Breastfeeding
- Any condition that, in the investigator's opinion, may interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Community Consortium / UCSF
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507, United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Univ TX Health Science Ctr
Houston, Texas, 77030, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049, United States
Related Publications (7)
Moyle GJ, DeJesus E, Cahn P, Castillo SA, Zhao H, Gordon DN, Craig C, Scott TR; Ziagen Once-Daily in Antiretroviral Combination Therapy (CNA30021) Study Team. Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):417-25. doi: 10.1097/01.qai.0000147521.34369.c9.
PMID: 15764958BACKGROUNDRibera E, Rodriguez-Pardo D, Rubio M, Soler A, Pedrol E, Blanco JL, Gonzalez A, Crespo M, Falco V, Ocana I, Deig E, Miro JM, Pahissa A. Efficacy and safety of once-daily combination therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive HIV-infected patients. Antivir Ther. 2005;10(5):605-14.
PMID: 16152754BACKGROUNDShlay JC, Visnegarwala F, Bartsch G, Wang J, Peng G, El-Sadr WM, Gibert C, Kotler D, Grunfeld C, Raghavan S; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Body composition and metabolic changes in antiretroviral-naive patients randomized to didanosine and stavudine vs. abacavir and lamivudine. J Acquir Immune Defic Syndr. 2005 Feb 1;38(2):147-55. doi: 10.1097/01.qai.0000143599.64234.15.
PMID: 15671799BACKGROUNDMacArthur RD, Chen L, Mayers DL, Besch CL, Novak R, van den Berg-Wolf M, Yurik T, Peng G, Schmetter B, Brizz B, Abrams D; CPCRA 058 FIRST Trial Study Team. The rationale and design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) trial. Control Clin Trials. 2001 Apr;22(2):176-90. doi: 10.1016/s0197-2456(01)00111-8.
PMID: 11306155RESULTTedaldi EM, Absalon J, Thomas AJ, Shlay JC, van den Berg-Wolf M. Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):441-8. doi: 10.1097/QAI.0b013e3181609da8.
PMID: 18176329RESULTvan den Berg-Wolf M, Hullsiek KH, Peng G, Kozal MJ, Novak RM, Chen L, Crane LR, Macarthur RD; CPCRA 058 Study Team, the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), and The International Network for Strategic Initiative in Global HIV Trials (INSIGHT). Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons. HIV Clin Trials. 2008 Sep-Oct;9(5):324-36. doi: 10.1310/hct0905-324.
PMID: 18977721RESULTMacArthur RD, Novak RM, Peng G, Chen L, Xiang Y, Hullsiek KH, Kozal MJ, van den Berg-Wolf M, Henely C, Schmetter B, Dehlinger M; CPCRA 058 Study Team; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). A comparison of three highly active antiretroviral treatment strategies consisting of non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or both in the presence of nucleoside reverse transcriptase inhibitors as initial therapy (CPCRA 058 FIRST Study): a long-term randomised trial. Lancet. 2006 Dec 16;368(9553):2125-35. doi: 10.1016/S0140-6736(06)69861-9.
PMID: 17174704RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rodger D. MacArthur, MD
University Health Center, Wayne State University
- STUDY CHAIR
Richard Novak, MD
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
January 1, 2003
Study Completion
June 1, 2006
Last Updated
April 17, 2014
Record last verified: 2014-04