Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments treatment initiation for hiv-1 group o infected patients, treatment initiation for hiv-1 group m infected patients
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date June 2010
End date August 2015
Trial size 171 participants
Trial identifier NCT00658346, ANRS 12168 DYNA M-O

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
HIV-1 group O infected patients
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)
HIV-1 group M infected patients
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)

Primary Outcomes

Measure
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
time frame: 48 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).