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

This study is currently recruiting participants.
Verified March 2012 by French National Agency for Research on AIDS and Viral Hepatitis
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00658346
First received: April 11, 2008
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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 aiming 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


Condition Intervention
HIV Infections
 Drug: Treatment initiation for HIV-1 group O infected patients
Drug: Treatment initiation for HIV-1 group M infected patients

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

plasma and mononucleus cells


Estimated Enrollment: 171
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
HIV-1 group O infected patients
 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 : D4T-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
  • If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)
2
HIV-1 group M infected patients
 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 : D4T-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
  • If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.

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:

  • On going traditional treatment which could interfere with hepatic function
  • On going treatment with rifabutin, rifampicin or rifampin
  • Acute hepatitis B infection
  • Pregnancy or lactating mother
  • HIV-1 group O and group M co-infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658346

Contacts
Contact: Jean-Christophe Plantier, Pharm D, PhD 33-02-3288-1462 jean-christophe.plantier@univ-rouen.fr
Contact: Charles Kouanfack, MD, MPH 237-9995-0743 charleskouanfack@yahoo.fr

Locations
Cameroon
Hôpital Central Recruiting
Yaounde, Cameroon
Contact: Charles Kouanfack, MD, PhD     237-9995-0743     charleskouanfack@yahoo.fr    
Principal Investigator: Charles Kouanfack, MD            
Hôpital de la CNPS Recruiting
Yaounde, Cameroon
Contact: Chantal Same-Ekobo, MD     +237 99 84 95 44     same@cameroun-online.com    
Contact: Peter Ngang, MD     +237 77 91 46 79     ngangbmvr@yahoo.co.uk    
Sub-Investigator: Same-Ekobo, MD            
Hôpital de district de Biyem Assi Recruiting
Yaoundé, Cameroon
Contact: Judith Mani , MD     00 237 99 95 74 18        
Contact: , MD            
Sub-Investigator: Judith Mani, MD            
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
  More Information

No publications provided

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00658346     History of Changes
Other Study ID Numbers: ANRS 12168 DYNA M-O
Study First Received: April 11, 2008
Last Updated: March 12, 2012
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV-1 group O
HIV-1 group M
Cameroon
HIV-1 infection
treatment naïve

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013