A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CLINICAL TRAIL TO COMPARE THE SAFETY AND EFFICACY OF REDUCED DOSE EFAVIRENZ (EFV) WITH STANDARD DOSE EFV PLUS TWO NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (N(T)RTI) IN ANTIRETROVIRAL -NAIVE HIV-INFECTED INDIVIDUAL OVER 96 WEEKS

Not Applicable

• Registration Number: PER-094-11
• Lead Sponsor: The Kirby Institute for infection and inmmunity in Society,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• HIV-1 POSITIVE AS FOR AUTHORIZED DIAGNOSTIC TEST.
• OVER 16 YEARS (OR MINIMUM AGE DETERMINED BY LOCAL RULES OR BE AUDITED BY LOCAL REQUIREMENTS).
• 50 • ≥ 1000 HIV RNA copies/ml
• PRE-TREATMENT WITHOUT ART EXHIBITION (INCLUDING TREATMENTS ANTIRETROVIRALS CLIPPED TO PREVENT VERTICAL TRANSMISSION OR MTCT)
• CALCULATED CREATININE CLEARANCE (CrCl) ≥ 50 mL/min (Cockcroft-GAULT).
• DELIVERY OF INFORMED CONSENT IN WRITING.

Exclusion Criteria

• LABORATORY VALUES FOLLOWING:
• ABSOLUTE NEUTROPHIL COUNT (ANC) <500 cells / µl
• HEMOGLOBIN <7.0 g / dL
• PLATELET COUNT <50,000 cells/µl
• AST AND/OR ALT> 5 x ULN
• PREGNANT OR NURSING MOTHERS
• OPPORTUNISTIC OR MALIGNANT DISEASES THAT ARE NOT ON ACTIVE CONTROL RIGHT
• IMMUNOMODULATING USE WITHIN 30 DAYS PRIOR TO THE VISIT OF SELECTION
• ANY MEDICATION USE PROHIBITED
• CURRENT CONSUMPTION OF ALCOHOL OR OTHER ILLEGAL SUBSTANCE THAT MAY ADVERSELY AFFECT PARTICIPATION IN THE STUDY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified