NCT00002033

Brief Summary

To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic function in HIV positive patients with advanced disease. To compare the effect of AS-101 to that of placebo on occurrence of disease progression in HIV positive patients with advanced disease as defined by: (1) development of new diagnostically confirmed major opportunistic infection(s); or (2) development of AIDS-related dementia. To compare the effect of zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and immunologic function in patients who require anti-viral therapy due to disease progression. Garlic capsules will be given to all study participants to mask the obvious garlic odor of AS-101.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency SyndromeAIDS-Related Complexammonium trichloro(dioxoethylene-O,O'-)telluruteZidovudine

Interventions

ZidovudineDRUG
AS-101DRUG

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Standard therapy including acyclovir or ganciclovir for infections that develop during the study period. (Prophylactic acyclovir is not permitted.) Standard therapy for persistent infections may continue.
  • Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor.
  • Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks.
  • Garlic capsules will be given to all study participants to mask side effects of AS-101.
  • Required:
  • Accepted standard prophylaxis for patients with prior Pneumocystis carinii pneumonia (PCP).
  • Patients must have the following:
  • Diagnosis of AIDS or AIDS-related complex (ARC).
  • Life expectancy \> 6 months.
  • Provide written informed consent.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Evidence of severe liver dysfunction (serum albumin \< 2.5 g/dl, prothrombin time \> 15 seconds or SGOT or SGPT \> 3 x upper limits of normal), gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorders which would prevent compliance with the protocol.
  • Evidence of AIDS related dementia.
  • Presence of disseminated Kaposi's sarcoma defined as any visceral lesions or \> 20 cutaneous lesions; or Kaposi's sarcoma without at least one other AIDS defining characteristic.
  • Presence of any lymphoma.
  • 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).
  • Concurrent Medication:
  • Excluded:
  • Prophylactic acyclovir.
  • Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor.
  • Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks.
  • Patients with the following are excluded:
  • Unlikely or unable to comply with the requirements of the protocol.
  • Prior Medication:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Escola Paulista De-Medicina

São Paulo, Brazil

Location

Faculdade De-Ciencias Medica Da

São Paulo, Brazil

Location

Hosp De-Servidor Publico Estadual

São Paulo, Brazil

Location

Instituto Do Cancer Arnaldo Vieiro

São Paulo, Brazil

Location

Related Publications (1)

  • Amarante JM, Levi GC, Pedro RJ, Galvao PA, Scheinberg M, Levy DS. A double blind controlled study with AS-101 in patients infected with HIV. Int Conf AIDS. 1992 Jul 19-24;8(2):B160 (abstract no PoB 3439)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudineammonium trichloro(dioxoethylene-O,O'-)tellurate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-02

Locations

BR(4)