---
title: A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
nct_id: NCT00002401
overall_status: COMPLETED
phase: NA
sponsor: Pharmacia and Upjohn
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00002401.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00002401"
ct_last_update_post_date: 2005-06-24
last_seen_at: "2026-05-12T07:15:50.913Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

**Official Title:** An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

**NCT ID:** [NCT00002401](https://clinicaltrials.gov/study/NCT00002401)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Pharmacia and Upjohn
- **Conditions:** HIV Infections
- **CT.gov Last Update:** 2005-06-24

## Brief Summary

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

## Detailed Description

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC\*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

* Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

## Eligibility

- **Minimum age:** 14 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior indinavir.
* Prior lamivudine.
* Prior protease inhibitors.
* Prior non-nucleoside reverse transcriptase inhibitors.
* 1 month or more prior zidovudine.

  1\. HIV-1 positive.
* CD4 coun tis above 50.
* HIV-1 RNA levels greater than 20,000.
```

## Interventions

- **Indinavir sulfate** (DRUG)
- **Delavirdine mesylate** (DRUG)
- **Lamivudine** (DRUG)
- **Zidovudine** (DRUG)

## Locations (1)

- Pharmacia & Upjohn, Peapack, New Jersey, United States

## Recent Field Changes (last 30 days)

- `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.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pharmacia & upjohn|peapack|new jersey|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00002401.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00002401*  
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