Status:
COMPLETED
Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Gilead Sciences
Janssen Pharmaceutica
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00928187
Start Date
November 1 2009
End Date
December 1 2015
Last Update
February 27 2017
Active Locations (3)
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1
Day Hospital, CHU Sanou Souro
Bobo-Dioulasso, Burkina Faso
2
Day Hospital, Central Hospital
Yaoundé, Cameroon
3
Clinical Research and Training Center, Fann Hospital
Dakar, Senegal