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

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

plasma and mononucleus cells


Enrollment:	141
Study Start Date:	June 2010
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)
Sexes Eligible for Study:	All
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:	January 11, 2017

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 June 26, 2017

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