Completed

Safety and Antiretroviral Activity Evaluation of HBY 097 and AZT in Asymptomatic or Mildly Symptomatic HIV Patients

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What is being tested

HBY 097

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorHoechst Marion Roussel
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks. PER AMENDMENT: Enrollment to the lowest dose cohort is completed.

NCT00002357
Principal SponsorHoechst Marion Roussel
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.
Design Details

144 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 13 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

8 inclusion criteria required to participate
Allowed: Treatment for opportunistic infection that develops on study
Asymptomatic or mildly symptomatic disease
CD4 count 200 - 500 cells/mm3
Consent of parent or guardian if less than legal age of consent
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29 exclusion criteria prevent from participating
Excluded at any time: Prior non-nucleoside reverse transcriptase inhibitors
Excluded within 30 days prior to study entry: An experimental device
Excluded within 30 days prior to study entry: Any antiretroviral therapy
Excluded within 30 days prior to study entry: Cytotoxic chemotherapeutic agents
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 6 locations

Los Angeles County - USC Med Ctr

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

Stanford Univ School of Medicine

Stanford, United States

Georgetown Univ Med Ctr

Washington D.C., United States

Med College of Georgia

Augusta, United States
Completed6 Study Centers