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| Descriptive Information Fields | |||||||||
| Brief Title † | 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) | ||||||||
| 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 | ||||||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 |
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| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine |
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| MEDLINE PMIDs | 11306155, 15764958, 16152754, 15671799 | ||||||||
| Links | Click here for more information about didanosine  Click here for more information about stavudine Click here for more information about nevirapine Click here for more information about lamivudine Click here for more information about indinavir sulfate Click here for more information about abacavir sulfate Click here for more information about nelfinavir mesylate Click here for more information about efavirenz Haga clic aquí para ver información sobre este ensayo clínico en español. Click here for more information on starting anti-HIV medications Haga clic aquí para más información acerca de cuándo empezar los medicamentos contra el VIH |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 1710 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000922 | ||||||||
| Organization ID | CPCRA 058 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | June 2005 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | September 11, 2008 | ||||||||
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