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

• Sponsor: ANRS, Emerging Infectious Diseases (Other)
• Overall Status: Completed
• CT.gov ID: NCT00658346
• Collaborator: (none)
• Enrollment: 141
• Locations: 2
• Duration (Months): 75
• Patients Per Site: 70.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Treatment initiation for HIV-1 group O infected patients; Drug: Treatment initiation for HIV-1 group M infected patients

Study Design

• Study Type: Observational
• Actual Enrollment: 141 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [48 weeks]

Secondary Outcome Measures

1. Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml [24 and 96 weeks]

2. Early and late slope of viral load decrease [between weeks 2 and 12, and week 24]

3. Early and late slope of CD4 counts increase [between weeks 2 and 12, and week 24]

4. Proportion of patients with a stabilized CD4 counts gain over 50% [96 weeks]

5. Time to virological failure [Through out the trial]

6. Resistance mutation profile when virological failure [Through out the trial]

7. Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification [Through out the trial]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Central	Yaounde		Cameroon
2	Hôpital de la CNPS	Yaounde		Cameroon

Sponsors and Collaborators

• ANRS, Emerging Infectious Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANRS, Emerging Infectious Diseases
• ClinicalTrials.gov Identifier: NCT00658346
• Other Study ID Numbers: ANRS 12168 DYNA M-O
• First Posted: Apr 15, 2008
• Last Update Posted: Jan 12, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by ANRS, Emerging Infectious Diseases: HIV-1 group O; HIV-1 group M; Cameroon; HIV-1 infection; treatment naïve
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Jan 12, 2017