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Ensayos clínicos

Ensayos clínicos

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)

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000922, CPCRA 058
  • Concluido

Propósito del estudio

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.

Afección:
Infecciones por el VIH

Detalles del estudio

Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens.



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.Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens.



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.

Criterios de inclusión

    • 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

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

California

    Community Consortium / UCSF, San Francisco, California, 94110, United States

Colorado

    Denver CPCRA / Denver Public Hlth, Denver, Colorado, 802044507, United States

Connecticut

    Yale Univ School of Medicine / AIDS Program, New Haven, Connecticut, 06510, United States

District of Columbia

    Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, 20422, United States

Georgia

    AIDS Research Consortium of Atlanta, Atlanta, Georgia, 303081962, United States

Illinois

    AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States

Louisiana

    Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States

Michigan

    Henry Ford Hosp, Detroit, Michigan, 48202, United States

    Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan, 48201, United States

New Jersey

    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

New Mexico

    Partners in Research / New Mexico, Albuquerque, New Mexico, 87131, United States

New York

    Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York, New York, 10037, United States

Oregon

    The Research and Education Group, Portland, Oregon, 97210, United States

Pennsylvania

    Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States

Texas

    Univ TX Health Science Ctr, Houston, Texas, 77030, United States

Virginia

    Richmond AIDS Consortium / Div of Infect Diseases, Richmond, Virginia, 232980049, United States

Actualizado: 6 de febrero del 2006

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