Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: March 11, 2014
Last verified: March 2014

April 11, 2008
March 11, 2014
June 2010
October 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 ] [ Designated as safety issue: No ]
Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Early and late slope of viral load decrease [ Time Frame: between weeks 2 and 12, and week 24 ] [ Designated as safety issue: No ]
  • Early and late slope of CD4 counts increase [ Time Frame: between weeks 2 and 12, and week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with a stabilized CD4 counts gain over 50% [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to virological failure [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Resistance mutation profile when virological failure [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  • Early and late slop of viral load decrease [ Time Frame: between 2 and 24 weeks ] [ Designated as safety issue: No ]
  • Early and late slop of CD4 counts increase [ Time Frame: between 2 and 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with a stabilized CD4 counts gain over 50% [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to virological failure [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Resistance mutation profile when virological failure [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
  • Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
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.
 
Active, not recruiting
171
October 2015
October 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT00658346
ANRS 12168 DYNA M-O
Yes
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)
March 2014

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