|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000922 |
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.
Condition | Intervention |
HIV Infections |
Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine |
MedlinePlus related topics: | AIDS AIDS Medicines |
Drug Information available for: | Abacavir Abacavir sulfate Lamivudine Indinavir Indinavir Sulfate Didanosine Stavudine Nelfinavir Nelfinavir Mesylate Efavirenz Nevirapine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 1710 |
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:
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Community Consortium / UCSF | |||||
San Francisco, California, United States, 94110 | |||||
United States, Colorado | |||||
Denver CPCRA / Denver Public Hlth | |||||
Denver, Colorado, United States, 802044507 | |||||
United States, Connecticut | |||||
Yale Univ School of Medicine / AIDS Program | |||||
New Haven, Connecticut, United States, 06510 | |||||
United States, District of Columbia | |||||
Washington Reg AIDS Prog / Dept of Infect Dis | |||||
Washington, District of Columbia, United States, 20422 | |||||
United States, Georgia | |||||
AIDS Research Consortium of Atlanta | |||||
Atlanta, Georgia, United States, 303081962 | |||||
United States, Illinois | |||||
AIDS Research Alliance - Chicago | |||||
Chicago, Illinois, United States, 60657 | |||||
United States, Louisiana | |||||
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Michigan | |||||
Henry Ford Hosp | |||||
Detroit, Michigan, United States, 48202 | |||||
Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |||||
Detroit, Michigan, United States, 48201 | |||||
United States, New Jersey | |||||
North Jersey Community Research Initiative | |||||
Newark, New Jersey, United States, 071032842 | |||||
Southern New Jersey AIDS Cln Trials / Dept of Med | |||||
Camden, New Jersey, United States, 08103 | |||||
United States, New Mexico | |||||
Partners in Research / New Mexico | |||||
Albuquerque, New Mexico, United States, 87131 | |||||
United States, New York | |||||
Harlem AIDS Treatment Grp / Harlem Hosp Ctr | |||||
New York, New York, United States, 10037 | |||||
United States, Oregon | |||||
The Research and Education Group | |||||
Portland, Oregon, United States, 97210 | |||||
United States, Pennsylvania | |||||
Philadelphia FIGHT | |||||
Philadelphia, Pennsylvania, United States, 19107 | |||||
United States, Texas | |||||
Univ TX Health Science Ctr | |||||
Houston, Texas, United States, 77030 | |||||
United States, Virginia | |||||
Richmond AIDS Consortium / Div of Infect Diseases | |||||
Richmond, Virginia, United States, 232980049 |
Study Chair: | Rodger D. MacArthur, MD | University Health Center, Wayne State University |
Study Chair: | Richard Novak, MD | University of Illinois |
Study ID Numbers: | CPCRA 058 |
First Received: | November 2, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000922 |
Health Authority: | United States: Federal Government |
|
|
|
|
|