HIV Infections Clinical Trial
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 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
Status | Completed |
Enrollment | 141 |
Est. completion date | September 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Cameroon | Hôpital Central | Yaounde | |
Cameroon | Hôpital de la CNPS | Yaounde |
Lead Sponsor | Collaborator |
---|---|
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
Cameroon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml | 48 weeks | No | |
Secondary | Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml | 24 and 96 weeks | No | |
Secondary | Early and late slope of viral load decrease | between weeks 2 and 12, and week 24 | No | |
Secondary | Early and late slope of CD4 counts increase | between weeks 2 and 12, and week 24 | No | |
Secondary | Proportion of patients with a stabilized CD4 counts gain over 50% | 96 weeks | No | |
Secondary | Time to virological failure | Through out the trial | No | |
Secondary | Resistance mutation profile when virological failure | Through out the trial | No | |
Secondary | Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification | Through out the trial | Yes |
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