Completed

Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Early Symptomatic HIV Infection

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What is being tested

Zidovudine

+ Acyclovir

Drug
Who is being recruted

Blood-Borne Infections+15

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
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 treating early symptomatic HIV infection. It aims to understand the long-term safety and effectiveness of using two medications, Retrovir (Zidovudine) and Zovirax (Acyclovir), together compared to using Retrovir alone. The research is important because it could help improve treatment strategies for HIV, potentially reducing the severity and onset of related infections and symptoms, while also considering the impact on the immune system and viral replication.

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 DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

Inclusion Criteria Patients must have: Early AIDS related complex (ARC). Willingness to be followed by the original study center for the duration of the trial (96 weeks). Ability to give informed consent. Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Fever > 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry. Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss). Concurrent Medication: Excluded: Acyclovir (ACV) therapy for chronic or recurrent herpes simplex. Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded. Prior Medication: Excluded within 4 weeks of study entry: Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity. Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2. Excluded within 8 weeks of study entry: Antiretroviral agents.

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 14 locations

Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, United StatesOpen Birmingham Veterans Administration Med Ctr / Univ of Alabama in Google Maps

Univ of Arizona / Health Science Ctr

Tucson, United States

ViRx Inc

San Francisco, United States

Georgetown Univ Med Ctr / Main Hosp 4

Washington D.C., United States
Completed14 Study Centers