MedPath

Study of Options for Second-Line Effective Combination Therapy (SELECT)

Phase 3
Conditions
Health Condition 1: null- HIV-1 Infection
Registration Number
CTRI/2018/04/013128
Lead Sponsor
ational Institute of Health NIH AIDS Clinical Trials Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

HIV-1 infected

Confirmation of first-line virologic failure

Certain laboratory values obtained within 45 days prior to study entry, •Negative pregnancy test within 48 hours prior to study entry.

Exclusion Criteria

1 Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days prior to study entry, with the exception of a tapering course of corticosteroids as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic obstructive pulmonary disease flare and/or prednisone at a daily dose of 10 mg (physiologic replacement dose)

2 If the potential participant has had resistance testing, evidence of broad NRTI cross-resistance that,

3 in the opinion of the investigator, would not allow selection of an effective NRTI combination if the participant were randomized to the LPV/r + best available NRTIs arm

4 Prior exposure to a Protease Inhibitor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath