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Completed

NCT Number: NCT00928187

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

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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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Day Hospital, CHU Sanou Souro, Bobo-Dioulasso, Burkina Faso

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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

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

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

Primary outcomes

  1. Number of Patients With Plasma HIV RNA < 50 Copies/mL

    Time frame: 48 weeks

Secondary outcomes

  1. Number of Patients With WHO Stage 3 and 4 HIV Related Events

    Time frame: between baseline and 48 weeks

    patients having a diagnosis of HIV related event classified as stage 3 or 4

  2. Patients With Plasma HIV RNA < 200 Copies/ml

    Time frame: 48 weeks

    number of patients with plasma HIV RNA below 200 copies/ml

  3. Gain in CD4 Cells Between Baseline and W48

    Time frame: between baseline and 48 weeks

    median gain in circulating CD4 cells between baseline and W48

  4. Number of Patients Discontinuing Study Treatment

    Time frame: between baseline and W48

    number of patients discounting treatment because of adverse events

  5. Tolerance: Gastrointestinal Complains

    Time frame: between baseline and 48 weeks

    Gastrointestinal complaints (grade 1 to 4) between baseline and W48.

  6. Tolerance: Neuropathies (Grade 1 to 4)

    Time frame: between baseline and W48

    any symptom of peripheral neuropathy

  7. Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)

    Time frame: between baseline and W48

    evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value

  8. Adherence

    Time frame: between baseline and W48

    number of patients in different categories of adherence as measured by questionnaire

  9. Number of Patients With Resistance Mutations

    Time frame: between W12 and W48

    number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)

  10. Development of Metabolic Syndrome

    Time frame: from baseline to week 48

    number of patients developing metabolic syndrome over a period of 48 weeks

  11. Number of Patients With HIV Plasma Viral Load < 50 Copies/ml

    Time frame: Week 24

    Snapshot of patients with HIV viral load less then 50 copies/ml at week 24

  12. Number of Patients With HIV Plasma Viral Load < 200 Copies/ml

    Time frame: Week 24

    number of patients having a plasma viral load below 200 copies/ml at week 24

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Gilead Sciences
  • Janssen Pharmaceutica

Registry information

Official study title

Multicentric, Non-inferiority, Randomized, Non-blinded Phase 3 Trial Comparing Virological Response at 48 Weeks of 3 Antiretroviral Treatment Regimens in HIV-1-infected Patients With Treatment Failure After 1st Line Antiretroviral Therapy (Cameroon, Burkina Faso, Senegal)

Acronym: 2LADY

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Jun 25, 2009
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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