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Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)

NCT00928187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2017-02-27

Study results available
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Summary

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.

This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)

Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening

DRUG

abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)

Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening

DRUG

emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)

Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Sinata Koulla Shiro, PhD · Infectious diseases department, Central Hospital, Yaounde, Cameroon

  • Papa Salif Sow, PhD · Infectious Diseases Department, Fann Hospital, Dakar, Senegal

  • Adrien Sawadogo, MD · Day Hospital, CHU Sanou Souro, Bobo Dioulasso, Burkina Faso

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-09-30
Completion
2015-12-31

Countries

  • Burkina Faso
  • Cameroon
  • Senegal

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00928187 on ClinicalTrials.gov