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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR COMPLERA


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All Clinical Trials for Complera

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01286740 ↗ Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR Completed Gilead Sciences Phase 2 2011-01-01 The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
NCT01777997 ↗ FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2013-04-25 This study was done with people who were infected with HIV, but did not show any signs of having HIV. They were also feeling well without taking HIV medication and had low or undetectable levels of the virus in the blood. The purpose of this study was to see if taking HIV medication (antiretroviral therapy [ART]) would reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but did not show symptoms. Also this study helped determine how safe the drug was and how well people reacted to the drug. For this study, the following antiretroviral therapy (ART) was be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided was one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who were taking HIV drugs for the first time. The risks seen with this HIV medication were the same that one would encounter when taking these drugs outside of the study.
NCT01777997 ↗ FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir Completed AIDS Clinical Trials Group Phase 4 2013-04-25 This study was done with people who were infected with HIV, but did not show any signs of having HIV. They were also feeling well without taking HIV medication and had low or undetectable levels of the virus in the blood. The purpose of this study was to see if taking HIV medication (antiretroviral therapy [ART]) would reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but did not show symptoms. Also this study helped determine how safe the drug was and how well people reacted to the drug. For this study, the following antiretroviral therapy (ART) was be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided was one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who were taking HIV drugs for the first time. The risks seen with this HIV medication were the same that one would encounter when taking these drugs outside of the study.
NCT02104700 ↗ Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir Completed Gilead Sciences Phase 2/Phase 3 2014-04-01 The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies: Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Complera

Condition Name

Condition Name for Complera
Intervention Trials
HIV-1 Infection 2
Healthy 1
Hepatitis C, Chronic 1
HIV 1
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Condition MeSH

Condition MeSH for Complera
Intervention Trials
Hepatitis C 1
Hepatitis 1
Coinfection 1
Acquired Immunodeficiency Syndrome 1
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Clinical Trial Locations for Complera

Trials by Country

Trials by Country for Complera
Location Trials
United States 28
Canada 2
Rwanda 1
Japan 1
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Trials by US State

Trials by US State for Complera
Location Trials
Massachusetts 3
Washington 2
Texas 2
Missouri 2
Illinois 2
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Clinical Trial Progress for Complera

Clinical Trial Phase

Clinical Trial Phase for Complera
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Complera
Clinical Trial Phase Trials
Completed 5
Unknown status 1
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Clinical Trial Sponsors for Complera

Sponsor Name

Sponsor Name for Complera
Sponsor Trials
Gilead Sciences 3
Janssen Pharmaceutical K.K. 1
Bayer 1
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Sponsor Type

Sponsor Type for Complera
Sponsor Trials
Other 5
Industry 5
NIH 1
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Clinical Trials, Market Analysis, and Projections for Complera

Introduction to Complera

Complera, a once-daily single tablet regimen, is a fixed-dose combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. It is indicated for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults and has been a significant addition to the arsenal of HIV therapies since its approval.

Clinical Trials Update

SPIRIT Study

One of the pivotal studies for Complera is the SPIRIT study (Study 106), a randomized, open-label Phase 3 trial. This study evaluated the non-inferiority of switching virologically suppressed HIV patients from a ritonavir-boosted protease inhibitor regimen to Complera. The primary endpoint was maintaining HIV RNA levels less than 50 copies/mL through 24 weeks of therapy.

  • Key Findings: The study met its 24-week primary endpoint, showing that 94% of patients who switched to Complera maintained viral suppression, compared to 90% of those who remained on the protease inhibitor regimen[1].
  • Virologic Response: At 24 weeks, the Complera arm had a virologic response rate of 94%, with only 0.9% experiencing virologic failure, compared to 5.0% in the protease inhibitor arm[1].
  • Safety Profile: The study also highlighted that Complera had a favorable safety profile, with fewer Grade 3 or 4 adverse events compared to the protease inhibitor regimen[1].

Other Studies

In addition to the SPIRIT study, Complera has been evaluated in other post-marketing studies. For example, Study 110 is an open-label Phase 3b head-to-head trial comparing Complera to Atripla among patients new to therapy. Study 111 is a Phase 2b open-label pilot study evaluating the efficacy and safety of switching virologically suppressed Atripla patients to Complera[1].

Market Analysis

Current Market Size and Trends

The global HIV drugs market, which includes Complera, was estimated to be approximately USD 34.26 billion in 2023. This market is expected to grow to USD 64.83 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 5.97%[5].

Complera Market Forecast

Complera falls under the category of multi-class combination drugs, which are a significant segment of the HIV drugs market. The market analysis for Complera indicates a positive growth trajectory driven by its efficacy, convenience, and the increasing demand for single-tablet regimens.

  • Revenue Projections: The market for multi-class combination drugs, including Complera, is expected to see substantial growth. While specific revenue projections for Complera are not detailed, the overall segment is anticipated to contribute significantly to the growing HIV drugs market[5].

Competitive Landscape

Complera competes with other multi-class combination drugs such as Atripla, Prezcobix, and Stribild. The competitive landscape is dynamic, with ongoing clinical trials and new drug approvals that could impact market share.

  • Gilead Sciences Performance: Gilead Sciences, the manufacturer of Complera, reported increased sales in the HIV segment in 2023, driven by higher demand for HIV and oncology products. This trend is expected to continue, supporting the growth of Complera and other HIV therapies[2].

Market Drivers and Challenges

Drivers

  • Efficacy and Convenience: Complera's once-daily dosing and single-tablet regimen make it a preferred option for many patients, contributing to its market growth.
  • Clinical Evidence: Positive outcomes from clinical trials, such as the SPIRIT study, reinforce the drug's efficacy and safety, further driving adoption[1].
  • Expanding Patient Population: The indication for Complera has been extended to include adolescent patients, expanding its potential market[4].

Challenges

  • Renal Impairment: Complera is not recommended for patients with moderate or severe renal impairment, which can limit its use in certain patient populations[1].
  • Competition: The HIV drugs market is highly competitive, with multiple multi-class combination drugs available. New drug approvals and changing treatment guidelines can impact Complera's market share[5].

Future Outlook

Emerging Trends

The HIV drugs market is evolving with advancements in antiretroviral therapies. The trend towards single-tablet regimens and once-daily dosing is expected to continue, benefiting drugs like Complera.

  • Innovation in HIV Therapies: Ongoing research and development in HIV treatments, including new drug classes and combination therapies, will continue to shape the market landscape[5].

Regulatory and Clinical Developments

  • Extended Indications: The extension of Complera's indication to include adolescent patients is a significant development, expanding its potential use[4].
  • Ongoing Studies: Continued post-marketing studies and real-world evidence will further establish Complera's safety and efficacy profile, supporting its market position.

Key Takeaways

  • Clinical Efficacy: Complera has demonstrated non-inferiority to protease inhibitor regimens in maintaining viral suppression.
  • Market Growth: The HIV drugs market, including Complera, is expected to grow significantly over the next decade.
  • Competitive Position: Complera's convenience and efficacy make it a strong competitor in the multi-class combination drug segment.
  • Regulatory Expansions: The drug's indication has been extended to adolescent patients, expanding its market potential.

FAQs

What is Complera used for?

Complera is used for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults and is also indicated for virologically suppressed patients switching from other regimens.

What are the key findings of the SPIRIT study?

The SPIRIT study found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen in maintaining HIV RNA levels less than 50 copies/mL through 24 weeks.

How does Complera compare to other HIV drugs in the market?

Complera competes with other multi-class combination drugs like Atripla and Prezcobix. Its once-daily dosing and single-tablet regimen make it a preferred option for many patients.

What are the potential challenges for Complera in the market?

Complera faces challenges such as its contraindication in patients with moderate or severe renal impairment and competition from other HIV therapies.

What is the projected market size for the HIV drugs market by 2034?

The global HIV drugs market is expected to reach approximately USD 64.83 billion by 2034, with a CAGR of 5.97%.

Sources

  1. Gilead Sciences, "Gilead's Once-Daily Single Tablet Regimen Complera® Maintains HIV Suppression Among Patients Switching From Protease Inhibitor-Based Regimens," 2012.
  2. Gilead Sciences, "Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results," 2024.
  3. PR Newswire, "Complement Inhibitors Market is Predicted to Exhibit Remarkable Growth During the Study Period 2020-2034," 2024.
  4. FDA, "Clinical Review: Emtricitabine/Rilpivirine/Tenofovir isoproxil fumarate," 2021.
  5. Research and Markets, "HIV Drugs Market Analysis & Forecast to 2024-2034," 2024.

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