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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-09-30

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

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

HIV-1 group O infected patients

Treatment initiation for HIV-1 group O infected patients

Intervention Type DRUG

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

Treatment initiation for HIV-1 group M infected patients

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No