Completed

Safety and Pharmacokinetics of AS-101 with Zidovudine in AIDS/ARC Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Zidovudine

+ AS-101

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on examining the safety and effectiveness of a drug called AS-101 when used together with another drug, Zidovudine (AZT), in patients diagnosed with AIDS or AIDS Related Complex (ARC). The main goal is to understand how this combination therapy works for these patients and how it might potentially improve their treatment. The study is particularly important as it aims to address the challenges faced in managing AIDS and ARC, and could pave the way for better care strategies for those affected by these conditions. During the study, participants will receive different dosages of AS-101 along with Zidovudine (AZT). The researchers will monitor various aspects such as how the body responds to these drugs, how the drugs interact within the body, and the impact of this combination on the immune system. They will also gather data related to neurocognitive functions. The study is designed to ensure the safety of the participants while gathering crucial information about the effectiveness of this combined treatment approach.

NCT00002013
Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
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.

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.

From 18 to 60 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 InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

11 inclusion criteria required to participate
Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis

Diagnosis of AIDS or AIDS related complex (ARC)

Provide informed written consent

Zidovudine (AZT)

Show More Criteria

13 exclusion criteria prevent from participating
Active opportunistic infection or malignancy requiring treatment at study entry

Active substance abuse

Dementia

Evidence of = or > 2 + proteinuria at 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 1 location

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google Maps
CompletedOne Study Center