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NCT01204905 · ClinicalTrials.gov registry record · NA

R5 Integrase Study in HIV-1 Naive Patients

A NA study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
7
Enrollment target

NCT01204905: Completed NA study, sponsored by University of Maryland, Baltimore.

NCT01204905 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01204905, a NA study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
7 participants
Enrollment target

Study Summary

This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously. This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.

Primary Outcome

Percentage of subjects with HIV-1 viral load \< 50 copies/ml

Interventions

  • DRUG Raltegravir and Maraviroc in combination

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-09
Est. Completion 2014-05-16
Phase NA
University of Maryland, Baltimore

560 total trials

What the finished NCT01204905 record still lists

NCT01204905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Raltegravir and Maraviroc in combination is the first listed.

NCT01204905 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01204905 about?

NCT01204905 is a clinical study titled "R5 Integrase Study in HIV-1 Naive Patients". This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these...

What is the current status of trial NCT01204905?

This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2010-09. Estimated completion is 2014-05-16.

What interventions are being tested in trial NCT01204905?

The interventions under investigation include: Raltegravir and Maraviroc in combination (DRUG).

Who is sponsoring clinical trial NCT01204905?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01204905's enrollment target sits among peer trials

7 1982nd of 2000 higher than 18 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01204905, the US trial registry maintained by the National Library of Medicine. NCT01204905 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.