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)
NCT ID: NCT00000922
Last Updated: 2014-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1710 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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Detailed Description
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Patients will be randomized to one of three HAART treatment arms:
* Arm 1 participants will receive one or two PIs plus two NRTIs.
* Arm 2 participants will receive one NNRTI plus two NRTIs.
* Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs.
Before randomization to a treatment arm, patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice. The study-specified NNRTIs will be nevirapine (NVP) or efavirenz (EFV). The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).
The study sites will provide ABC, 3TC, ddI, or d4T to all patients who are assigned to take these medications. All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription. At Months 1 and 4 and then every 4 months thereafter, patients will receive a medical history update, physical exam, and questionnaire. Blood samples will also be drawn to measure CD4 cell count, viral load, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Indinavir sulfate
Abacavir sulfate
Nelfinavir mesylate
Efavirenz
Nevirapine
Lamivudine
Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Are unable to complete the study for any reason
* Pregnancy
* Breastfeeding
* Any condition that, in the investigator's opinion, may interfere with the study
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Rodger D. MacArthur, MD
Role: STUDY_CHAIR
University Health Center, Wayne State University
Richard Novak, MD
Role: STUDY_CHAIR
University of Illinois at Chicago
Locations
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Community Consortium / UCSF
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States
Countries
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References
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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.
Ribera 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.
Shlay 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.
MacArthur 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.
Tedaldi 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.
van 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.
MacArthur 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.
Other Identifiers
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11611
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 058
Identifier Type: -
Identifier Source: org_study_id
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