NCT00658346

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

5.2 years

First QC Date

April 11, 2008

Last Update Submit

January 11, 2017

Conditions

HIV Infections

Keywords

HIV-1 group OHIV-1 group MCameroonHIV-1 infectiontreatment naïve

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml

    48 weeks

Secondary Outcomes (7)

  • 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

  • Proportion of patients with a stabilized CD4 counts gain over 50%

    96 weeks

  • Time to virological failure

    Through out the trial

  • +2 more secondary outcomes

Study Arms (2)

1

HIV-1 group O infected patients

Drug: Treatment initiation for HIV-1 group O infected patients

2

HIV-1 group M infected patients

Drug: Treatment initiation for HIV-1 group M infected patients

Interventions

Treatment initiation for HIV-1 group O infected patientsDRUG

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)

1
Treatment initiation for HIV-1 group M infected patientsDRUG

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)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Central

Yaoundé, Cameroon

Location

Hôpital de la CNPS

Yaoundé, Cameroon

Location

Related Publications (1)

  • 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.

    PMID: 31063537DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma and mononucleus cells

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2008

First Posted

April 15, 2008

Study Start

June 1, 2010

Primary Completion

August 1, 2015

Study Completion

September 1, 2016

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

CA(2)