---
title: The Safety and Effectiveness of 524W91
nct_id: NCT00002335
overall_status: COMPLETED
phase: PHASE1
sponsor: Glaxo Wellcome
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00002335.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00002335"
ct_last_update_post_date: 2005-06-24
last_seen_at: "2026-05-12T06:47:35.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Safety and Effectiveness of 524W91

**Official Title:** A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91

**NCT ID:** [NCT00002335](https://clinicaltrials.gov/study/NCT00002335)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Glaxo Wellcome
- **Conditions:** HIV Infections
- **CT.gov Last Update:** 2005-06-24

## Brief Summary

To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.

## Detailed Description

Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \>= 200 cells/mm3.
* No active opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy or other condition that would confound study assessment or interfere with ability to complete the study.
* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with gastrointestinal absorption.

Concurrent Medication:

Excluded on the day of each dose:

* Antiretrovirals.
* Any prescription or over-the-counter medication.
* Alcoholic beverages.
* Coffee, tea, and other xanthine-containing beverages and foods.

Patients with the following prior conditions are excluded:

History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years.

Prior Medication:

Excluded:

* Antiretrovirals within 24 hours prior to each dose.
* Any prescription or over-the-counter medications within 48 hours prior to each dose.
* Alcoholic beverages within 48 hours prior to each dose. Current alcohol or illicit drug use that may affect patient compliance.
```

## Interventions

- **Emtricitabine** (DRUG)

## Locations (1)

- ViRx Inc, San Francisco, California, United States

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `locations.virx inc|san francisco|california|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00002335.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00002335*  
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