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)
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|ClinicalTrials.gov Identifier: NCT00000922|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1710 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 2003|
|Actual Study Completion Date :||June 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000922
|Study Chair:||Rodger D. MacArthur, MD||University Health Center, Wayne State University|
|Study Chair:||Richard Novak, MD||University of Illinois at Chicago|