search
Back to results

The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Acyclovir
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acyclovir, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Veterans Administration Med Ctr / Univ of Alabama
  • Univ of Arizona / Health Science Ctr
  • ViRx Inc
  • Georgetown Univ Med Ctr / Main Hosp 4
  • Veterans Administration Med Ctr
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Harper Hosp
  • Univ of Pennsylvania / HIV Clinic
  • Vanderbilt School of Medicine
  • Univ TX Galveston Med Branch
  • Baylor College of Medicine
  • Univ of Utah School of Medicine
  • Univ of Virginia Health Sciences Ctr
  • Richmond AIDS Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00002290
Brief Title
The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
Official Title
A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic Human Immunodeficiency Virus (HIV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acyclovir, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Birmingham Veterans Administration Med Ctr / Univ of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
Georgetown Univ Med Ctr / Main Hosp 4
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33504
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ of Pennsylvania / HIV Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Univ of Virginia Health Sciences Ctr
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

We'll reach out to this number within 24 hrs