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COMPLETED Phase 3

Comparative Study of Three NNRTI-Sparing HAART Regimens

NCT00811954 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Atazanavir
  • DRUG Raltegravir
  • DRUG Emtricitabine/tenofovir disoproxil fumarate
  • DRUG Darunavir

Study Locations (20)

California

  • Miller Children's Hospital — Long Beach
  • USC CRS — Los Angeles
  • UCLA CARE Center CRS — Los Angeles
  • Stanford CRS — Palo Alto
  • Ucsd, Avrc Crs — San Diego
  • Ucsf Aids Crs — San Francisco
  • Harbor-UCLA Med. Ctr. CRS — Torrance

Florida

  • South Florida Childrens Diagnostic & Treatment Cen (5055) — Fort Lauderdale
  • University of Florida Jacksonville (5051) — Jacksonville
  • Univ. of Miami AIDS CRS — Miami

Colorado

  • University of Colorado Hospital CRS — Aurora
  • Denver Public Health CRS — Denver

District of Columbia

  • Georgetown University CRS (GU CRS) — Washington D.C.
  • Howard Univ. Washington DC NICHD CRS — Washington D.C.

Illinois

  • Northwestern University CRS — Chicago
  • Rush Univ. Med. Ctr. ACTG CRS — Chicago

Alabama

  • Alabama Therapeutics CRS — Birmingham

Georgia

  • The Ponce de Leon Center CRS — Atlanta

Louisiana

  • Tulane University New Orleans NICHD CRS (5095) — New Orleans

Trial Details

FieldValue
Enrollment Target 1,814 participants
Start Date 2009-05
Est. Completion 2013-06
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00811954

The ClinicalTrials.gov registry entry for NCT00811954 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,814 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 5 interventions — of which Ritonavir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00811954 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00811954 about?

NCT00811954 is a clinical study titled "Comparative Study of Three NNRTI-Sparing HAART Regimens". 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 ma...

What is the current status of trial NCT00811954?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,814 participants. The study started on 2009-05. Estimated completion is 2013-06.

What conditions does trial NCT00811954 study?

This clinical trial studies the following conditions: HIV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00811954?

The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Raltegravir (DRUG), Emtricitabine/tenofovir disoproxil fumarate (DRUG), Darunavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00811954?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00811954 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial