MedTrace Logo

First-Line Treatment for HIV-2

NCT02150993 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2019-07-22

No results posted yet for this study

Summary

FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo).

ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.

The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2 infected adult patients, in West Africa. A treatment will be considered as effective if more than 55% of patients in that arm attain "global success" at 96 weeks.

Conditions

  • HIV-2 Infection

Interventions

DRUG

Tenofovir + Emtricitabine or Lamivudine + Zidovudine

TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + ZDV (Zidovudine 300 mg) 1 tb BID (mornings and evenings orally)

DRUG

Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + Lop/r (Lopinavir/ritonavir lopinavir 200/50 mg) 2 tbs BID (mornings and evenings orally)

DRUG

Tenofovir + Emtricitabine or Lamivudine + Raltegravir

TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + RAL (Raltegravir 400 mg) 1 tb BID (mornings and evenings orally)

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Serge P. Eholié, MD, MSc, Pr · Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire

  • Françoise P. Brun-Vézinet, MD, MSc, Pr · Laboratoire de virologie, Hôpital Bichat-Claude Bernard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-26
Primary Completion
2019-05-15
Completion
2019-05-15

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Senegal
  • Togo

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150993 on ClinicalTrials.gov