Completed

Zidovudine Dose-Ranging Study for HIV Disease Management

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What is being tested

Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+20 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 finding the right oral dose of a drug called zidovudine (AZT) for patients with HIV disease, specifically those in CDC Classification Groups IIB, III, and IV-C2. The drug has shown potential in reducing significant events and death in patients with AIDS, Pneumocystis carinii pneumonia (PCP), and AIDS related complex (ARC). The goal is to understand if AZT can be used effectively in all stages of HIV disease without causing significant toxicity. During the study, patients with documented HIV viremia who are in good health will receive AZT in increasing doses. The study measures the drug's toxicity, how well it reduces viremia, if it improves immune function, and if it prevents further manifestation of HIV disease. The drug levels in the patients will also be monitored and compared with the toxicity and viremia levels.

NCT00002023
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 InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

6 inclusion criteria required to participate
Patients must have HIV reactivity.
ECOG performance status 0 or 1.
Patients with = or <= involuntary 10 percent weight loss in the last 6 months.
Positive antibody for HIV by an ELISA test kit. If the ELISA is negative, then eligibility will be confirmed by second confirmatory test, i.e., immunoblot.
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14 exclusion criteria prevent from participating
Drugs which cause anemia or neutropenia.
HIV antibody negative by immunoblot.
Other antiretroviral agents.
Class IV-C2 with prior history of multidermal herpes zoster, oral candidiasis on more than one occasion, or tuberculosis.
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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 1 location

Glaxo Wellcome Inc

Research Triangle Park, United StatesOpen Glaxo Wellcome Inc in Google Maps
CompletedOne Study Center