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
|
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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 or disease | Intervention/treatment |
---|---|
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 |
Actual Enrollment : | 141 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | September 2016 |

Group/Cohort | Intervention/treatment |
---|---|
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 :
|
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 :
|
- Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [ Time Frame: 48 weeks ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658346
Cameroon | |
Hôpital Central | |
Yaounde, Cameroon | |
Hôpital de la CNPS | |
Yaounde, Cameroon |
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 |
First Posted: | April 15, 2008 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | January 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 |