MedDataX Logo

A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

NCT ID: NCT00002367

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saquinavir

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients must have:

* Plasma HIV-1 RNA titers \> 10,000 copies/ml.
* CD4 cell count \> 100 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions will be excluded:

* Any prior anti-retroviral drug therapy.

Prior Medication:

Excluded:

Previous anti-retroviral drug therapy.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AIDS Healthcare Foundation Labs

Los Angeles, California, United States

Site Status

Urgent Care Ctr / North Broward Hosp District

Fort Lauderdale, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NR15503

Identifier Type: -

Identifier Source: secondary_id

M61005

Identifier Type: -

Identifier Source: secondary_id

229F

Identifier Type: -

Identifier Source: org_study_id