Completed

Safety and Efficacy of MDL 28,574A in HIV-Infected Patients

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What is being tested

Celgosivir hydrochloride

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorHoechst Marion Roussel
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on understanding the safety and effectiveness of a drug called MDL 28,574A in treating patients with HIV infection. The HIV infection is at an early stage, either without symptoms or with mild symptoms. The study aims to find out how well the drug works when given alone and when combined with another HIV medication, zidovudine (AZT). By conducting this research, the study hopes to improve treatment options for HIV patients and address the challenges associated with managing this condition. During the study, participants receive fixed doses of MDL 28,574A, either by itself or in combination with AZT. The study then examines how the drug affects different demographic groups by looking at its pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body). This helps the researchers understand the safety and effectiveness of MDL 28,574A for various populations. Participants' health and response to treatment are closely monitored throughout the study.

NCT00002151
Principal SponsorHoechst Marion Roussel
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections

Criteria

4 inclusion criteria required to participate
Allowed: Prior antiretroviral agents for up to 6 months per agent

Asymptomatic or mildly symptomatic

CD4 count 301 - 500 cells/mm3

HIV infection

12 exclusion criteria prevent from participating
Antiretroviral therapy within 2 weeks prior to study entry

Any investigational drug with a washout < 5 half-lives prior to study entry

Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry

Biological response modifiers within 30 days prior to study entry

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 24 locations

Clinical Investigations Health Services

Mobile, United StatesOpen Clinical Investigations Health Services in Google Maps

California Clinical Trials Med Group

Beverly Hills, United States

Southwest Community Based AIDS Treatment Group - COMBAT

Los Angeles, United States

UCSF - San Francisco Gen Hosp

San Francisco, United States
Completed24 Study Centers