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Protease Inhibitor

Arm A: ATV/RTV + FTC/TDF for HIV/AIDS

Phase 3
Waitlist Available
Research Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 4, 24, 48, 96, and 144
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed. This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 4, 24, 48, 96, and 144
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 4, 24, 48, 96, and 144 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96
Cumulative Probability of First Virologic Failure by Week 96
Secondary study objectives
CD4+ T-cell Count
CD4+ T-cell Count Changes From Baseline
Change in Fasting HDL Cholesterol Level From Baseline
+14 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: DRV/RTV + FTC/TDFExperimental Treatment3 Interventions
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Group II: Arm B: RAL + FTC/TDFExperimental Treatment2 Interventions
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Group III: Arm A: ATV/RTV + FTC/TDFExperimental Treatment3 Interventions
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emtricitabine
FDA approved
Ritonavir
FDA approved
Atazanavir
FDA approved
Raltegravir
FDA approved
Darunavir
FDA approved

Find a Location

Who is running the clinical trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsLead Sponsor
99 Previous Clinical Trials
71,758 Total Patients Enrolled
AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
71,809 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,320 Previous Clinical Trials
5,362,831 Total Patients Enrolled
~110 spots leftby Nov 2025
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