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

• 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 ]

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

HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.

• 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)
• 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)

• 1
  HIV-1 group O infected patients
  Intervention: Drug: Treatment initiation for HIV-1 group O infected patients
• 2
  HIV-1 group M infected patients
  Intervention: Drug: Treatment initiation for HIV-1 group M infected patients

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