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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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-094-11
Enrollment
90
Registered
2012-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

APPROXIMATELY 630 PARTICIPANTS will be randomized 1:1 (315:315) AND THEN BE ASSIGNED TO ONE OF THE FOLLOWING GROUPS OF TREATMENT: I. TENOFOVIR 600 mg + EFV (TDF) (300mg qd) / EMTRICITABINE (FTC) (2
100,000 COPIES/ML AT TIME OF SELECTION. THE PRIMARY END POINT OF INTEREST WILL ESTABLISH THE PERCENTAGE OF PARTICIPANTS WITH A LEVEL IN PLASMA HIV RNA OF <200 copies/ml 48 RANDOMING WEEKS AFTER WHI

Sponsors

The Kirby Institute for infection and inmmunity in Society,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

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 <CD4 <350 cells/µL OR PRIOR AIDS DEFINING ILLNESS. • &#8805; 1000 HIV RNA copies/ml • PRE-TREATMENT WITHOUT ART EXHIBITION (INCLUDING TREATMENTS ANTIRETROVIRALS CLIPPED TO PREVENT VERTICAL TRANSMISSION OR MTCT) • CALCULATED CREATININE CLEARANCE (CrCl) &#8805; 50 mL/min (Cockcroft-GAULT). • DELIVERY OF INFORMED CONSENT IN WRITING.

Exclusion criteria

Exclusion criteria: • LABORATORY VALUES FOLLOWING: • ABSOLUTE NEUTROPHIL COUNT (ANC) 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.

Countries

Germany, Thailand, United Kindgdom

Outcome results

None listed

Source: REPEC (via WHO ICTRP)