A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients
Status:
Completed
Trial end date:
1999-09-01
Target enrollment:
Participant gender:
Summary
To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo)
and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients
with plasma HIV RNA levels below the limit of detection [AS PER AMENDMENT 8/27/97: < 500
copies/ml at week 16]. To evaluate the safety and tolerance of the study arms. [AS PER
AMENDMENT 3/10/99: During the extension period, compare the time to detectable viremia (2
consecutive plasma HIV RNA levels greater than or equal to 500 copies/ml) between ABC and
placebo.] Therapeutically, there is a need to explore potent alternative therapy for patients
who have received, or are currently receiving, a double nucleoside analog combination
including lamivudine (3TC), a regimen that was proven to be clinically inferior to indinavir
(IDV) when combined with zidovudine/3TC in study ACTG 320. In order to produce and maintain a
maximal antiviral response, all patients in this study will receive 2 or 3 potent, new
agents; ABC, a nucleoside analog, EFV, a non-nucleoside reverse transcriptase inhibitor
(NNRTI), and IDV, a protease inhibitor. Virologically, the major question this protocol seeks
to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to
subsequent treatment. It is unclear whether it is best to add a protease inhibitor either 1)
an NNRTI at 1 of 2 doses, or 2) an NNRTI at 1 of 2 doses plus a new nucleoside analog to
achieve plasma HIV RNA levels that are below the limits of detection.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)