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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: July 11, 2016
Last verified: July 2016
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 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


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 Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
plasma and mononucleus cells

Estimated Enrollment: 171
Study Start Date: June 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: August 2015 (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 : TDF-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 : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
  • If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658346

Locations
Cameroon
Hôpital Central
Yaounde, Cameroon
Hôpital de la CNPS
Yaounde, Cameroon
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  More Information

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     History of Changes
Other Study ID Numbers: ANRS 12168 DYNA M-O 
Study First Received: April 11, 2008
Last Updated: July 11, 2016
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-1 group O
HIV-1 group M
Cameroon
HIV-1 infection
treatment naïve

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

ClinicalTrials.gov processed this record on September 27, 2016