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

January 11, 2017 updated by: ANRS, Emerging Infectious Diseases

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaounde, Cameroon
        • Hôpital Central
      • Yaounde, Cameroon
        • Hôpital de la CNPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
HIV-1 group O infected patients
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)
2
HIV-1 group M infected patients
Drug: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12168 DYNA M-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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