Clinical trial NCT00658346: Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Official title: Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-1 group O
HIV-1 group M
Cameroon
HIV-1 infection
treatment naïve
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2008-04-15
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
timeFrame: 24 and 96 weeks
measure: Early and late slope of viral load decrease
timeFrame: between weeks 2 and 12, and week 24
measure: Early and late slope of CD4 counts increase
timeFrame: between weeks 2 and 12, and week 24
measure: Proportion of patients with a stabilized CD4 counts gain over 50%
timeFrame: 96 weeks
measure: Time to virological failure
timeFrame: Through out the trial
measure: Resistance mutation profile when virological failure
timeFrame: Through out the trial
measure: Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification
timeFrame: Through out the trial
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Hôpital Central
city: Yaounde
country: Cameroon
facility: Hôpital de la CNPS
Study officials:
References:
citation: Kouanfack C, Unal G, Schaeffer L, Kfutwah A, Aghokeng A, Mougnutou R, Tchemgui-Noumsi N, Alessandri-Gradt E, Delaporte E, Simon F, Vray M, Plantier JC; ANRS 12168 DynaMO Study. Comparative Immunovirological and Clinical Responses to Antiretroviral Therapy Between HIV-1 Group O and HIV-1 Group M Infected Patients. Clin Infect Dis. 2020 Mar 17;70(7):1471-1477. doi: 10.1093/cid/ciz371.