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NCT Number: NCT00658346

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Central, Yaoundé, Cameroon

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment initiation for HIV-1 group O infected patients

Drug

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 patients

Drug

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)

Primary outcomes

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

    Time frame: 48 weeks

Secondary outcomes

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

    Time frame: 24 and 96 weeks

  2. Early and late slope of viral load decrease

    Time frame: between weeks 2 and 12, and week 24

  3. Early and late slope of CD4 counts increase

    Time frame: between weeks 2 and 12, and week 24

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

    Time frame: 96 weeks

  5. Time to virological failure

    Time frame: Through out the trial

  6. Resistance mutation profile when virological failure

    Time frame: Through out the trial

  7. Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification

    Time frame: Through out the trial

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Apr 15, 2008
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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