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HIV-1 InfectionPhase 2FATI-01NCT01714414

A Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen

A Phase 2 study testing FZD, 3TC and EFV in people with HIV-1 Infection, run by Michael Hoelscher at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of treatment in ART naïve, non subtype B HIV-1 infected… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
FZD, 3TC and EFV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesin 2 countries
Study dates
Dec 2012to Feb 2017
Phase
Phase 2
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

Who may be able to join

  • Male or female ≥ 18 years of age.
  • Provide written or thump printed informed consent prior to all trial-related procedures
  • HIV-1 positive with an indication to start antiretroviral therapy (ART) according to WHO and/or country guidelines
  • ART naïve, including no history of antiretroviral medication during PMTCT or PEP
  • Patient agrees not to take any concomitant medication during the trial without informing the investigator. Traditional medicines should be specified with concomitant medications.
  • Availability throughout the study
Show all 17Show fewer
  • Female patients of childbearing potential must have a negative pregnancy test and agree to use a highly effective method of birth control throughout participation in the trial and for 10 weeks after last dose (to cover duration of ovulation).
  • Agree to have home visits or active tracing if lost to follow up or any other event justifying a rapid visit of the patient at the clinical trial centre.
  • CD4 count ≥100 cells/μl
  • Hb ≥9.5 g/dl
  • Platelets ≥50,000 cells/mm3
  • Neutrophils ≥500 cells/ mm3
  • Bilirubin <2.5 x uln
  • ALT <2.5 x uln
  • Exclusion of Severe hepatic insufficiency (PT<50%)
  • Creatinine clearance calculated by Cockroft's formula ≥50 ml/min
  • Urine dipstick for protein and blood: negative or trace

Who cannot join

  • Deficiency in the patient, rendering it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her
  • Presence of an uncontrolled, ongoing, opportunistic infection or of any severe or progressive disease including active TB or any other justified reason which in the opinion of the investigator could significantly inhibit study procedures. This includes any clinical signs possibly associated with any WHO stage 3 or 4, with still unconfirmed diagnosis such as fever, weight loss, diarrhoea or unexplained cough.
  • HIV-2 infection
  • Pregnancy or lactating mother
  • Unlikely to comply with protocol as judged by the principal investigator or his designate
  • Use of experimental therapeutic agents within 30 days of study entry.
  • Hepatitis B with positive HBsAg.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Côte d’Ivoire1 site

  • Service des Maladies Infectieuses et Tropicales, CHU de Treichville,

    Abidjan, BPV3

Other trials in Côte d’Ivoire

Tanzania1 site

  • NIMR - Mbeya Medical Research Programme,

    Mbeya, PO Box 2410

Other trials in Tanzania

About this study

Official title: A Prospective, Multicenter, Open, Randomized Phase 2a Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen After 24 Weeks of Treatment in ART naïve, Non Subtype B HIV-1 Infected Individuals From Tanzania and Ivory Coast

A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory Coast.

Read the detailed description

The study will evaluate four different oral 1st line antiretroviral regimens: three study arms will contain different doses of Fozivudine (FZD) plus Lamivudine (3TC) in a twice daily or once daily application plus once daily Efavirenz. The 4th study arm will contain standard Zidovudine (AZT)/Lamivudine (3TC) twice daily in a fixed dose combination plus once daily Efavirenz. The treatment duration will be 24 weeks.

In a pharmacokinetic Sub-Study Pharmacokinetic (PK) characteristics will be determined under controlled conditions in a sub population to evaluate PK values of the study drugs.

Primary Objective

The primary objective is to confirm a sustained virological suppression (HIV RNA <50 copies/ml) after 24 weeks of treatment between three different doses of Fozivudine (FZD) based antiretroviral 1st line treatment regimen in context to a standard Zidovudine (ZDV) based treatment regimen in non subtype B HIV-1 infected individuals from Africa.

Secondary Objectives

  1. HIV-RNA log10 reduction of HIV-RNA at 2, 4 and 8 weeks of treatment between different arms
  2. Virological response (HIV RNA <50 copies/ml) at 8 and 12 weeks of treatment between different arms
  3. Virological response (HIV RNA <400 copies/ml) at 8, 12 and 24 weeks of treatment between different arms
  4. Immunologic response: variation in CD4 lymphocytes between different arms
  5. Drug toxicity, particularly anaemia, neutropenia and gastrointestinal adverse events
  6. Resistance pattern for in patients with virological failure
  7. Clinical trial capacity building of African study sites within the FATI network
  8. Establishment of a Fozivudine Drug developing consortium (NET) including members of pharmaceutical manufacturers in Asia, Africa and Europe.
  9. Development and piloting of a capacity development monitoring and evaluation framework

Pharmacological Objectives

  1. Pharmacokinetic assessments after the first intake of study drugs in a subset of study participants (Pharmacokinetic sub study)
  2. Pharmacokinetic assessments at steady state after four weeks of study drugs in a subset of study participants (Pharmacokinetic sub study)

Study Population and Study Duration

A total of 120 ART naive HIV-1 infected individuals with the indication to start antiretroviral treatment according to WHO and country guidelines will be enrolled at two study sites in Côte d'Ivoire and Tanzania. Each of the two sites will enroll 60 participants (15 participants per arm). For the PK Sub-Study 6 participants per study arm (total 24 participants will be included.

A minimum of 30% gender representation (female or male) participants will be requested per site. Recruitment, screening and enrollment of study participants are expected to be completed after 9 months. Patient treatment is 24 weeks. So patient related study procedures will take 15 months.

Conditions
HIV-1 Infection
Being tested
FZD, 3TC, EFV, AZT
Keywords
HIV, Fozivudine, Zidovudine, FATI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FZDDrug

    Also called Fozivudine

  • 3TCDrug

    Also called Lamivudine

  • EFVDrug

    Also called Efavirenz

  • AZTDrug

    Also called Zidovudine

Study groups in NCT01714414
Study groupRoleWhat they receive
FZD 600mg twice dailyExperimentalFZD 3 tablets (600mg) twice daily / 3TC 1 tablet (150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
Receives: Drug: FZD; Drug: 3TC; Drug: EFV
FZD 800mg once dailyExperimentalFZD 4 tablets (800mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
Receives: Drug: FZD; Drug: 3TC; Drug: EFV
FZD 1200mg once dailyExperimentalFZD 6 tablets (1200mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
Receives: Drug: FZD; Drug: 3TC; Drug: EFV
AZT twice dailyActive comparator1 tablet Combivir(AZT 300mg/3TC 150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
Receives: Drug: 3TC; Drug: EFV; Drug: AZT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with plasma HIV RNA < 50 copies/ml

    Measured: at week 24

Secondary outcomes (10)

  1. Proportion of patients with plasma HIV RNA <50 copies/ml

    Measured: at week 8 and 12

  2. Proportion of patients with plasma HIV RNA < 400 copies/ml

    Measured: at week 8, 12 and 24

  3. Mean HIV log10 reduction compared to baseline

    Measured: at week 2, 4 and 8

  4. Variation of circulating total lymphocyte count

    Measured: up to week 24

  5. Variation of circulating CD4+ lymphocyte count

    Measured: up to week 24

  6. Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) before and after the first dose

    Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed before the first treatment and during the course of 12 hours after the first treatment.

    Measured: Day 1

  7. Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) at steady state

    Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed during the course of 12 hours after 4 weeks of treatment.

    Measured: Week 4

  8. Proportion of clinical events stage 3 or 4 of WHO HIV classification

    Measured: up to week 24

  9. Number of participants with Adverse Events as Measure of safety and tolerability

    The number of Adverse Events and also the quality, severity and relatedness to study drug are documented and analysed.

    Measured: up to week 24

  10. Incidence of resistance mutations after confirmed treatment failure (confirmed HIV RNA > 1000 copies/ml

    Measured: at week 12 and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2014
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714414
Sponsor's protocol ID
LMU-IMPH-FATI-01
Acronym
FATI-01
Status last verified
Mar 2018
First submitted
25 Oct 2012
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FZD, 3TC and EFV in people with HIV-1 Infection, run by Michael Hoelscher at 2 sites in 2 countries.

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 17 inclusion and 7 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 7 Mar 2018. 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 Côte d’Ivoire, Tanzania. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 plasma HIV RNA < 50 copies/ml (time frame: at week 24). 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 NCT01714414.

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 7 Mar 2018.

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