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Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00658346
First received: April 11, 2008
Last updated: January 11, 2017
Last verified: January 2017

April 11, 2008
January 11, 2017
June 2010
August 2015   (Final data collection date for primary outcome measure)
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [ Time Frame: 48 weeks ]
Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00658346 on ClinicalTrials.gov Archive Site
  • Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [ Time Frame: 24 and 96 weeks ]
  • Early and late slope of viral load decrease [ Time Frame: between weeks 2 and 12, and week 24 ]
  • Early and late slope of CD4 counts increase [ Time Frame: between weeks 2 and 12, and week 24 ]
  • Proportion of patients with a stabilized CD4 counts gain over 50% [ Time Frame: 96 weeks ]
  • Time to virological failure [ Time Frame: Through out the trial ]
  • Resistance mutation profile when virological failure [ Time Frame: Through out the trial ]
  • Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification [ Time Frame: Through out the trial ]
  • Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 24 and 96 weeks ]
  • Early and late slop of viral load decrease [ Time Frame: between 2 and 24 weeks ]
  • Early and late slop of CD4 counts increase [ Time Frame: between 2 and 24 weeks ]
  • Proportion of patients with a stabilized CD4 counts gain over 50% [ Time Frame: 96 weeks ]
  • Time to virological failure [ Time Frame: Through out the trial ]
  • Resistance mutation profile when virological failure [ Time Frame: Through out the trial ]
  • Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification [ Time Frame: Through out the trial ]
Not Provided
Not Provided
 
Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon

Infections with HIV-1 group O are found in 1 to 3 % of persons living with HIV in Cameroon. The natural history and treatment response is not well understood. The natural resistance to non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to protease inhibitors complicate the choice of an adequate treatment options.

This observational study is aimed at evaluating the antiretroviral treatment response of HIV-1 group O infected patients in comparison with HIV-1 group M infected patients. The proposed standardized follow-up will facilitate a better understanding of the natural history and treatment specificities to improve the patients management.

This is a non randomized study, open label, with standardized follow-up. A total of 171 patients

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
plasma and mononucleus cells
Non-Probability Sample
HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.
HIV Infections
  • Drug: Treatment initiation for HIV-1 group O infected patients

    The first line regimen is adapted according to the hemoglobin level and the AgHBs status :

    • If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
    • If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
    • If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)
  • Drug: Treatment initiation for HIV-1 group M infected patients

    The first line regimen is adapted according to the hemoglobin level and the AgHBs status :

    • If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
    • If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
    • If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)
  • 1
    HIV-1 group O infected patients
    Intervention: Drug: Treatment initiation for HIV-1 group O infected patients
  • 2
    HIV-1 group M infected patients
    Intervention: Drug: Treatment initiation for HIV-1 group M infected patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 2016
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 group O or group M infection
  • No history of antiretroviral treatment (except for PMTCT)
  • Criteria for treatment initiation according to the Cameroons national guidelines

Exclusion Criteria:

  • Ongoing traditional treatment which could interfere with hepatic function
  • Ongoing treatment with rifabutin, rifampicin or rifampin
  • Acute hepatitis B infection
  • Pregnancy or lactating mother
  • HIV-1 group O and group M co-infection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
 
NCT00658346
ANRS 12168 DYNA M-O
Yes
Not Provided
Not Provided
Not Provided
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Not Provided
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP