Completed

AS-101 Impact on Clinical Efficacy and Immunologic Function in Advanced HIV Positive 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 13 to 70 Years
+19 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 HIV positive patients with advanced disease. Its main goal is to compare the effects of a drug called AS-101 and a placebo on clinical efficacy and immunologic function. The study also aims to evaluate how these two treatments affect the progression of the disease. This research is important as it could potentially improve the care and treatment strategies for patients with advanced HIV disease. During the study, participants receive either AS-101 or a placebo intravenously. For those who require anti-viral therapy due to disease progression, the effects of zidovudine (AZT) plus AS-101 are compared to AZT alone. To ensure blinding, all participants are given garlic capsules, as AS-101 has a notable garlic odor. The study measures the results by monitoring the occurrence of disease progression, defined by the development of new major opportunistic infections or AIDS-related dementia.

NCT00002033
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 13 to 70 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

8 inclusion criteria required to participate
Accepted standard prophylaxis for patients with prior Pneumocystis carinii pneumonia (PCP)
Diagnosis of AIDS or AIDS-related complex (ARC)
Garlic capsules will be given to all study participants to mask side effects of AS-101
Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor
Show More Criteria
11 exclusion criteria prevent from participating
Active opportunistic infection currently requiring treatment unless the infection has stabilized and continuing treatment is only required to prevent relapse (e.g., CNS toxoplasmosis or resolving tuberculosis)
Any immune stimulation agents such as BCG vaccine, interferons, or other immune modulators within 8 weeks
Any immunosuppressive agent within 8 weeks
Evidence of AIDS related dementia
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 4 locations

Escola Paulista De-Medicina

São Paulo, BrazilOpen Escola Paulista De-Medicina in Google Maps

Faculdade De-Ciencias Medica Da

São Paulo, Brazil

Hosp De-Servidor Publico Estadual

São Paulo, Brazil

Instituto Do Cancer Arnaldo Vieiro

São Paulo, Brazil
Completed4 Study Centers
AS-101 Impact on Clinical Efficacy and Immunologic Function in Advanced HIV Positive Patients | PatLynk