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

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

Study Type: Observational

Study Design: Case Control, Prospective

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • HIV-1 group O infected patients
• : 2
  • HIV-1 group M infected patients

Primary Measures

• Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml
  • Time Frame: 48 weeks
    Safety Issue?: No

Secondary Measures

• Proportion of patients with plasmatic HIV viral load bellow 50 copies / ml
  • Time Frame: 24 and 96 weeks
    Safety Issue?: No
• Early and late slop of viral load decrease
  • Time Frame: between 2 and 24 weeks
    Safety Issue?: No
• Early and late slop of CD4 counts increase
  • Time Frame: between 2 and 24 weeks
    Safety Issue?: No
• Proportion of patients with a stabilized CD4 counts gain over 50%
  • Time Frame: 96 weeks
    Safety Issue?: No
• Time to virological failure
  • Time Frame: Through out the trial
    Safety Issue?: No
• Resistance mutation profile when virological failure
  • Time Frame: Through out the trial
    Safety Issue?: No
• Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification
  • Time Frame: Through out the trial
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Overall Clinical Trial Officials and Contacts

Overall Contact: Jean-Christophe Plantier, Pharm D, PhD 33-02-3288-1462 jean-christophe.plantier@univ-rouen.fr

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00658346

Study ID Number: ANRS 12168 DYNA M-O

ClinicalTrials.gov Identifier: NCT00658346

Health Authority: Cameroon: Ministry of Public Health