Multicenter Study of Options for Effective SEcond-Line Combination Therapy Among HIV-1 infected Individuals Failing First-line Antiretroviral Therapy

Phase 3

• Conditions: Health Condition 1: null- HIV Infected

• Registration Number: CTRI/2012/10/003035
• Lead Sponsor: AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

Inclusion Criteria

HIV 1 infected

Confirmation of first line virologic failure

Certain laboratory values obtained within 45 days prior to study entry More information on this criterion can be found in the study protocol

Negative pregnancy test within 48 hours prior to study entry

Must refrain from participating in a conception process and if participating in sexual activity that could lead to pregnancy must use at least one acceptable type of contraceptive More information on this criterion can be found in the study protocol

Ability and willingness of participant or legal guardian representative to provide informed consent

Exclusion Criteria

Exclusion Criteria:

•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).

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

•Prior exposure to a Protease Inhibitor.

•Known history of congenital long QT syndrome, hypokalemia, or planned use of other drugs that prolong the QT interval.

•Pregnancy or breast-feeding.

•Known history of chronic hepatitis B virus (HBV) infection or current HBV infection defined by the presence of hepatitis B surface antigen in serum or plasma.

•Active tuberculosis (TB) requiring treatment with rifampicin.

•Previously diagnosed malignancies other than basal cell carcinoma and cutaneous Kaposi sarcoma.

•Requirement for taking any medications that are prohibited with the study drugs. More information on this criterion can be found in the study protocol, section 5.4.

•Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.

•Active drug or alcohol use or dependence or other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.

•Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified