Completed

Thymopentin and Antiretroviral Therapy in Asymptomatic HIV-Infected Patients

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What is being tested

Thymopentin

+ Stavudine

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorImmunobiology Research Institute
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-infected individuals who do not show any symptoms and are currently receiving either single or combination anti-retroviral therapy. The main goal is to validate the results from a previous study that found a slower disease progression when combining thymopentin with zidovudine (AZT), an antiretroviral drug. Additionally, the study aims to evaluate the effectiveness and safety of thymopentin in HIV-infected asymptomatic patients who are undergoing monotherapy with AZT, didanosine (ddI), or stavudine (d4T), or combination therapy with AZT/ddI or AZT/zalcitabine (ddC). This research is important as it could lead to improved treatment options and a better quality of life for individuals living with HIV. During the study, participants will continue their current anti-retroviral therapy while also receiving thymopentin. The effects of this combination will be carefully monitored to assess the safety and efficacy of thymopentin. The study will measure how well the treatment slows disease progression and manages HIV-related symptoms. It's important to note that like all clinical trials, this study comes with potential risks and benefits, which will be thoroughly explained to participants before they decide to take part.

NCT00002109
Principal SponsorImmunobiology Research Institute
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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

6 inclusion criteria required to participate
Asymptomatic HIV infection

At least 6 months of prior AZT

CD4 count 100-400 cells/mm3

No HIV-associated neurologic abnormalities or constitutional symptoms

Show More Criteria

22 exclusion criteria prevent from participating
Abnormal chest x-ray, consistent with active opportunistic infection

Bacillary angiomatosis

Grade 2 or worse peripheral neuropathy

Herpes zoster (within the past year)

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 50 locations

Fisher Med Group

Phoenix, United StatesOpen Fisher Med Group in Google Maps

Ctr for Special Immunology

Irvine, United States

Beer Med Group

Los Angeles, United States

Gottlieb Med Group

Pasadena, United States
Completed50 Study Centers