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

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00658346

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:	Case Control, Prospective
Official Title:	Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon

Resource links provided by NLM:

MedlinePlus related topics: 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

Biospecimen Description:

plasma and mononucleus cells

Estimated Enrollment:	171
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (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
Yaounde, Cameroon
Hôpital Militaire
Yaounde, Cameroon
Hôpital Général
Yaounde, Cameroon
Hôpital de la CNPS
Yaounde, Cameroon

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 ( Claire Rekacewicz )
Study ID Numbers:	ANRS 12168 DYNA M-O
Study First Received:	April 11, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00658346 History of Changes
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:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010