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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00658346

Enrollment

141

Registered

2008-04-15

Start date

2010-06-30

Completion date

2016-09-30

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1 group O, HIV-1 group M, Cameroon, HIV-1 infection, treatment naïve

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

Interventions

DRUGTreatment 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)

DRUGTreatment initiation for HIV-1 group M infected patients

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
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
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
Time to virological failure	Through out the trial

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026