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Completed

NCT Number: NCT02733419

Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

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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

Interventional

Phase

Phase 3

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with HIV-1 infection
  • Female participants without any risk of pregnancy
  • Participants previously treated with drugs of 2 or 3 different antiretroviral classes
  • Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)
  • Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes
  • Cluster of differentiation 4 (CD4) cell count greater than (>) 50 cells/cubic millimeter (mm^3) at screening
  • Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes
  • Enfuvirtide-naive participants

Exclusion criteria

  • Women of childbearing age not using effective mechanical contraception
  • Pregnant or breastfeeding women
  • Presence of HIV-2 coinfection
  • Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial
  • Participants having previously been treated with enfuvirtide
  • Presence active opportunistic infection within 1 month of study entry
  • Existence of Grade 4 clinical or laboratory abnormalities
  • Cirrhosis or severe hepatic failure
  • Uncontrolled diabetes or requiring insulin
  • Consumption of alcohol and/or narcotics and/or other substances

Treatment and study plan

Enfuvirtide

Drug

Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.

Other names: Fuzeon

Optimized background antiretroviral regimen (OB)

Drug

Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.

Primary outcomes

  1. Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52

    Time frame: Week 52

Secondary outcomes

  1. Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)

    Time frame: Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52

  2. Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score

    Time frame: Weeks 2, 4, 8, and 24

  3. Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score

    Time frame: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal

  4. Change from baseline in viral load

    Time frame: Baseline up to Week 52 or premature withdrawal

  5. Proviral deoxyribonucleic acid (DNA) level

    Time frame: Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal

  6. Time to reappearance of viral load above 50 copies/mL in randomized participants

    Time frame: 52 weeks

  7. Changes from baseline in CD4 and CD8 cell counts

    Time frame: Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal

  8. Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA

    Time frame: Day 0 (inclusion) up to Week 52

  9. Number of participants with cause of virologic failure

    Time frame: Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal

  10. Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied

    Time frame: Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52

  11. Number of participants with adverse events

    Time frame: Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)

  12. Number of participants with missed treatment doses or injections as assessed by compliance questionnaire

    Time frame: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal

  13. Number of participants with injection site reaction

    Time frame: Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 11, 2016
Registry last updated
Apr 11, 2016

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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