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

Study Overview
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Brief Summary
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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

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Treatment initiation for HIV-1 group O infected patients
* Drug: Treatment initiation for HIV-1 group M infected patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HIV-1 group O infected patients | Drug: Treatment initiation for HIV-1 group O infected patients<br>* 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)<br>|
| 2<br>HIV-1 group M infected patients | Drug: Treatment initiation for HIV-1 group M infected patients<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml |  | 24 and 96 weeks | 
| Early and late slope of viral load decrease |  | between weeks 2 and 12, and week 24 | 
| Early and late slope of CD4 counts increase |  | between weeks 2 and 12, and week 24 | 
| Proportion of patients with a stabilized CD4 counts gain over 50% |  | 96 weeks | 
| Time to virological failure |  | Through out the trial | 
| Resistance mutation profile when virological failure |  | Through out the trial | 
| Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification |  | Through out the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 group O, HIV-1 group M, Cameroon, HIV-1 infection, treatment naïve