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

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ClinicalTrials.gov Identifier: NCT00658346
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : January 12, 2017
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)

Tracking Information
First Submitted Date April 11, 2008
First Posted Date April 15, 2008
Last Update Posted Date January 12, 2017
Study Start Date June 2010
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2014)
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [ Time Frame: 48 weeks ]
Original Primary Outcome Measures
 (submitted: April 14, 2008)
Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 48 weeks ]
Change History Complete list of historical versions of study NCT00658346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 11, 2014)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: April 14, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Official Title Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Brief Summary

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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma and mononucleus cells
Sampling Method Non-Probability Sample
Study Population HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.
Condition HIV Infections
Intervention
  • 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)
Study Groups/Cohorts
  • 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
Publications * Kouanfack C, Unal G, Schaeffer L, Kfutwah A, Aghokeng A, Mougnutou R, Tchemgui-Noumsi N, Alessandri-Gradt E, Delaporte E, Simon F, Vray M, Plantier JC. Comparative immuno-virological and clinical responses to antiretroviral therapy between HIV-1 group O- and HIV-1 group M-infected patients (ANRS 12168 DynaMO study). Clin Infect Dis. 2019 May 7. pii: ciz371. doi: 10.1093/cid/ciz371. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2017)
141
Original Estimated Enrollment
 (submitted: April 14, 2008)
171
Actual Study Completion Date September 2016
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Cameroon
Removed Location Countries  
 
Administrative Information
NCT Number NCT00658346
Other Study ID Numbers ANRS 12168 DYNA M-O
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators Not Provided
Investigators Not Provided
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date January 2017