Completed

AZT vs Placebo Impact on AIDS and AIDS Related Complex Progression

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What is being tested

Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on treating AIDS and AIDS-related conditions, specifically in patients with ARC (AIDS-Related Complex). It aims to compare the effectiveness of a drug called zidovudine (AZT) against a placebo. The main goal is to see if AZT can slow down the progression to AIDS or death, which includes conditions like major infections, dementia, and cancers. The study also wants to understand how AZT affects the immune system and the HIV virus itself. It's important because it could help improve treatment and care for people living with HIV and ARC. During the study, participants will either receive AZT or a placebo. The effect of these treatments will be measured by tracking the time it takes for the patients' CD4 lymphocyte concentration (a type of white blood cell that fights infections) to drop by at least 25 percent from the starting point. The study will also look at how well AZT can reduce or control HIV. Additionally, it will monitor any long-term side effects of AZT on various body systems like blood, liver, kidneys, skin, digestive system, and the brain. The study will also observe the natural progression of ARC in patients receiving the placebo.

NCT00002063
Principal SponsorGlaxo Wellcome
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.

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

1 inclusion criteria required to participate
Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
28 exclusion criteria prevent from participating
- Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or other meningitis. (The decision to perform invasive tests, such as lumbar puncture, specialized microbiological tests such as bone marrow culture for Mycobacteria or Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI should be based on clinical assessment of the patient.)
- Unstable disease.
- Kaposi's sarcoma.
- Kaposi's sarcoma.
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 8 locations

Wadsworth Veterans Administration Med Ctr

Los Angeles, United StatesOpen Wadsworth Veterans Administration Med Ctr in Google Maps

San Francisco Veterans Administration Med Ctr

San Francisco, United States

Walter Reed Army Med Ctr

Washington D.C., United States

Veterans Administration Med Ctr

Washington D.C., United States
Completed8 Study Centers