HIV InfectionsNCT00658346
Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 2 sites in Cameroon.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Treatment initiation for HIV-1 group O infected patients and Treatment initiation for HIV-1 group M infected patients
- How many people
- 141 participants
- Where
- 2 sitesCameroon
- Study dates
- Jun 2010to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Conditions
- HIV Infections
- Being tested
- Treatment initiation for HIV-1 group O infected patients, Treatment initiation for HIV-1 group M infected patients
- Keywords
- HIV-1 group O, HIV-1 group M, Cameroon, HIV-1 infection, treatment naïve
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-1 group O infected patients Receives: Drug: Treatment initiation for HIV-1 group O infected patients | |
| 2 | HIV-1 group M infected patients Receives: Drug: Treatment initiation for HIV-1 group M infected patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
Measured: 48 weeks
Secondary outcomes (7)
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
Measured: 24 and 96 weeks
Early and late slope of viral load decrease
Measured: between weeks 2 and 12, and week 24
Early and late slope of CD4 counts increase
Measured: between weeks 2 and 12, and week 24
Proportion of patients with a stabilized CD4 counts gain over 50%
Measured: 96 weeks
Time to virological failure
Measured: Through out the trial
Resistance mutation profile when virological failure
Measured: Through out the trial
Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification
Measured: Through out the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJun 2010
- Primary completionAug 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658346
- Sponsor's protocol ID
- ANRS 12168 DYNA M-O
- Status last verified
- Jan 2017
- First submitted
- 11 Apr 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31063537
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
- ClinicalTrials.gov ID
- NCT00658346
- Acronym / sponsor ID
- ANRS 12168 DYNA M-O
- Conditions
- HIV Infections
- Keywords
- HIV-1 group O, HIV-1 group M, Cameroon, HIV-1 infection, treatment naïve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jun 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Treatment initiation for HIV-1 group O infected patientsHIV-1 group O infected patients |
| 2 | – | Drug: Treatment initiation for HIV-1 group M infected patientsHIV-1 group M infected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected patients coming for medical care in four treatment centers in Yaounde.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment initiation for HIV-1 group O infected patientsThe 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) | Drug | 1 |
| Treatment initiation for HIV-1 group M infected patientsThe 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) | Drug | 2 |
Primary outcome
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
Time frame: 48 weeks
7 secondary outcomes
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
Time frame: 24 and 96 weeks
Early and late slope of viral load decrease
Time frame: 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
Proportion of patients with a stabilized CD4 counts gain over 50%
Time frame: 96 weeks
Time to virological failure
Time frame: Through out the trial
Resistance mutation profile when virological failure
Time frame: Through out the trial
Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification
Time frame: Through out the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 31063537Kouanfack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 2 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.