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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Treatment initiation for HIV-1 group O infected patients; Drug: Treatment initiation for HIV-1 group M infected patients

• Registration Number: NCT00658346
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Study Start: 2010-06
• Primary Completion: 2015-08
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Treatment initiation for HIV-1 group O infected patients	HIV-1 group O infected patients
2	Treatment initiation for HIV-1 group M infected patients	HIV-1 group M infected patients

Primary Outcome Measures

Name	Time	Method
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml	48 weeks

Secondary Outcome Measures

Name	Time	Method
Time to virological failure	Through out the trial
Proportion of patients with a stabilized CD4 counts gain over 50%	96 weeks
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml	24 and 96 weeks
Early and late slope of viral load decrease	between weeks 2 and 12, and week 24
Early and late slope of CD4 counts increase	between weeks 2 and 12, and week 24
Resistance mutation profile when virological failure	Through out the trial
Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification	Through out the trial

Trial Locations

Locations (2)

Hôpital Central; 🇨🇲 Yaounde, Cameroon

Hôpital de la CNPS; 🇨🇲 Yaounde, Cameroon