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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Arm B

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Arm C

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient over the age of 18 years at pre-inclusion and monitored under outpatient conditions
* Documented HIV-1 infection regardless of clinical stage and CD4 lymphocyte count
* Patient with treatment failure after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors, failure being defined as 2 measurements (at 1 month interval) of plasma HIV RNA levels \> 1000 copies/ml after at least 6 months of uninterrupted treatment
* Adherence (\> 80%) to first- line antiretroviral treatment (questionnaire) at pre inclusion
* Patient agrees not to take any concomitant medication during the trial without informing the investigator
* Informed consent signed no later than D-15
* For women in childbearing age: negative pregnancy test at inclusion, with no plan of pregnancy in the coming 12 months and agreeing to use mechanical contraception (with or without hormonal contraception) during the study

Exclusion Criteria

* Infection with HIV-2 or HIV-1 groups O or N or HIV1+2
* Deficiency of the patient, making it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her
* Participation in any other clinical trial
* Presence of an uncontrolled, ongoing opportunistic infection or of any severe or progressive disease
* First-line treatment with a protease inhibitor, abacavir, tenofovir or ddI
* Ongoing treatment with rifampicin
* Severe hepatic insufficiency (TP \< 50%)
* ALAT \> 3 x ULN
* Creatinine clearance calculated by Cockcroft formula \< 50 ml/min
* Hb ≤ 8 g/dl
* Platelets \< 50,000 cells/mm3
* Neutrophiles \< 500 cells/ mm3
* Use of drugs prohibited in the context of this trial (drugs contraindicated by the SCP of the trial drugs) - in the event of tuberculosis or malaria during the trial, a list of authorized medicines and, if necessary, a dose adjustment of the antiretroviral medication will be provided
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No