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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658346
• Other study ID #: ANRS 12168 DYNA M-O
• Status: Completed
• Phase: N/A
• First received: April 11, 2008
• Last updated: January 11, 2017
• Start date: June 2010
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

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 : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA) If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)
• 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)

Locations

Country	Name	City	State
Cameroon	Hôpital Central	Yaounde
Cameroon	Hôpital de la CNPS	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

Cameroon, 

Outcome

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