Phase 3 HIV and AIDS Trial, Completed NCT00426660 Sponsor: ViiV Healthcare Condition: HIV and AIDS
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,047 people, all of whom received the HIV medication maraviroc. Of those, 1,032 were included in the safety analysis, and 916 completed the study. The trial was designed to track a range of safety-related measurements in people taking maraviroc, including how often participants experienced serious side effects, abnormal blood test results, AIDS-defining illnesses (serious conditions that can occur when the immune system is severely weakened), and other HIV-related infections or cancers. The reported data shows that 13.2% of participants experienced a Grade 3 ("severe") adverse event — meaning a side effect serious enough to interrupt daily life — and 2.4% experienced a Grade 4 ("very severe") adverse event, defined as intolerable, irreversible, or life-threatening. When looking only at side effects considered possibly related to the study drug, those figures were 6.3% and 1.6% respectively. For abnormal blood test results, the reported data shows a range of figures across different tests: Grade 3 (severe) abnormalities ranged from roughly 0.2% to 4.7% depending on the specific test, while Grade 4 (very severe) abnormalities ranged from 0% to about 1.5%. The percentage of participants who developed AIDS-defining illnesses was low across the categories measured, with most figures reported at 0.1% to 0.6%. The reported data shows that no measurements were submitted for the two outcome measures examining AIDS-related infections and cancers broken down by starting viral load or CD4 cell count (a measure of immune system strength). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 HIV and AIDS Trial, Completed

NCT00426660
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your current HIV treatment is not working well enough, and a recent blood test shows your HIV virus levels are at 1,000 copies per milliliter or higher
  • Your HIV virus is a specific type called "R5" (also known as CCR5-tropic), confirmed by a specific laboratory test called the Trofile assay
  • You are at least 16 years old, or meet the minimum adult age required in your country

Who may not be able to join:

  • You have previously tried and failed a type of HIV medication called a "CCR5 antagonist" (a drug that blocks a protein the virus uses to enter cells), or you are currently in another trial using this type of drug, or you previously stopped taking a drug called Maraviroc early while in a clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
ViiV Healthcare
Registry
ClinicalTrials.gov
Start date
1 February 2007
Est. completion
1 June 2010

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile Costa Rica Dominican Republic 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇮🇳 India 🇮🇪 Ireland 🇮🇹 Italy 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE); Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities; Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities; Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses; Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load; Percentage of Participants With Possible Acquired Immunodeficiency Syndrom...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov