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HIVPhase 3PHI04NCT01694420

Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet

A Phase 3 study testing (FDC) ELV/COBI/FTC/TDF in people with HIV, run by Duke University at 2 sites in United States.

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

This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Participants will be enrolled for 96 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HIV
What is being tested?
(FDC) ELV/COBI/FTC/TDF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
Sep 2012to Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute HIV Infection (as defined above) within 30 days of study entry.
  • Age >18 years.
  • ART-naive (<14 days of previous antiretroviral treatment. Exceptions are: Post-exposure prophylaxis (PEP) if participant was documented as HIV-negative at least 3 months after completion of PEP.
  • Lab values within 30 days prior to study entry:
  • Absolute neutrophil count >500/mm3
  • Hemoglobin > 8.5 g/dL for men and > 8.0 g/dL for women
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  • Platelet count >50,000/mm3
  • AST (SGOT)> .2.5 x ULN
  • ALT (SGPT)> .2.5 x ULN
  • Total bilirubin <2.5 x ULN
  • Calculated creatinine clearance (Cockcroft-Gault formula) > 70mL/min:
  • For women of reproductive potential, a negative pregnancy test within 72 hours prior to initiating antiretroviral study medications. Reproductive potential is defined as females who have reached menarche and have not been post-menopausal for at least 24 consecutive months, or have not undergone surgical sterilization.
  • Female study participants must use a reliable form of barrier contraception, such as a condom, even if they also use other methods of birth control. All participants must continue to use contraception for 12 weeks after stopping study medications. Acceptable methods of barrier contraception include: condoms (male or female), diaphragm, or cervical cap. These can be used alone or in tandem with hormonal or IUD method.
  • Ability and willingness of participant to give written informed consent.

Who cannot join

  • Women who are pregnant or breast-feeding.
  • Women with a positive pregnancy test prior to study drug administration.
  • Men who have sex with women, and women of reproductive potential unwilling or unable to use an acceptable, reliable barrier method of contraception for the entire study period and 12 weeks afterwards.
  • Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days of study entry (Prednisone 10 mg QD or less is permitted.
  • Known allergy/sensitivity to study drugs
  • Difficulty swallowing pills
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  • Inability to communicate effectively with study personnel
  • Incarceration; prisoner recruitment and participation are not permitted
  • Active drug or alcohol use that, in the opinion of the site investigator, would interfere with participation in the study
  • Any active psychiatric illness that, in the opinion of the investigator, could confound the analysis of the neurological examination or neuropsychological test results
  • Active brain infection (except for HIV-1), brain neoplasm, space-occupying brain lesion requiring acute or chronic therapy
  • Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry
  • Known cardiac conduction disease
  • Prior treatment with any other experimental drug within 30 days of initiating study treatment
  • Unable to discontinue any current medications that are excluded during study treatment
  • Life expectancy less than twelve months
  • Acute Viral Hepatitis, including, but not limited to, Hepatitis A, B, or C
  • Chronic Hepatitis B Infection documented by a detectable serum Hepatitis B surface antigen (HBsAg) or plasma HBV DNA
  • Calculated creatinine clearance (Cockcroft-Gault formula) <70mL/min

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UNC at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Duke University Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Treatment of Acute HIV Infection With the Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate, A Pilot Study of Response to Therapy and HIV Pathogenesis

This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48, clinical care but not study drug will be provided through week 96. A study participant suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.

The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV), cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The secondary hypotheses to be considered are 1) virologic response rates as measured by plasma HIV RNA levels will be non-inferior or superior to a historical group of participants from the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of participants samples will be obtained from compartments such as the gastrointestinal tract, and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir) will be quantitated and compared to similar measurements in PHI participants treated with EFV/FTC/TDF. In addition, we will compare these results to those measured in HIV-1 infected participants treated and 6) ELV/COBI/FTC/TDF will be well tolerated, and the proportion of participants who require treatment modification will be less than that observed in participants treated with EFV/FTC/TDF.

Read the detailed description

None desired

Conditions
HIV
Being tested
(FDC) ELV/COBI/FTC/TDF

What participants receive

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

  • (FDC) ELV/COBI/FTC/TDFDrug

    Also called STRIBILD

    Antiretroviral treatment

Study groups in NCT01694420
Study groupRoleWhat they receive
Quad FDCExperimentalFDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
Receives: Drug: (FDC) ELV/COBI/FTC/TDF

What is being measured

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

  1. Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24

    Measured: 24 weeks

  2. Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48

    Measured: 48 weeks

Secondary outcomes (2)

  1. Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+

    Measured: 48 weeks

  2. Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF

    Measured: 48 weeks

Timeline

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

  1. First posted27 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2016
  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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01694420
Sponsor's protocol ID
Pro00035447
Other IDs
IN-US-236-0124
Acronym
PHI04
Status last verified
Mar 2017
First submitted
21 Sep 2012
Last updated
12 Apr 2017
Data monitoring committee
No

Publications

  • Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 2011 Apr 24;25(7):941-9. doi: 10.1097/QAD.0b013e3283463c07.

    PubMed 21487250

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing (FDC) ELV/COBI/FTC/TDF in people with HIV, run by Duke University at 2 sites in United States.

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 14 inclusion and 19 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 Apr 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24 (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01694420, 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 Apr 2017.

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