Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
Status:
Completed
Trial end date:
2001-07-01
Target enrollment:
Participant gender:
Summary
To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater
than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug
regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir
(NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV
alone, in the treatment of patients with advanced HIV disease who have received limited or no
prior antiretroviral therapy.
Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in
improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced
effects seen with combination therapies are likely related to a greater suppression of RNA
replication and alterations in resistance patterns. Due to the progressive success of
combination regimens, it is possible that more potent regimens will further enhance viral
suppression and provide more durable treatment responses. In light of the additive
suppression of HIV replication determined by pharmacological, immunological, and virological
results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the
potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral
replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will
also be evaluated as an addition to IDV/ZDV/3TC.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Efavirenz Indinavir Lamivudine Lamivudine, zidovudine drug combination Nelfinavir Zidovudine