Completed

Phase 3
Age: 13Years +
All Genders
ID00001022

A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

1200

Participants Needed

16

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients. Secondary: To compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels. Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

CONDITIONS

Official Title

A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Required:

  • Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
  • CD4+ cell count = or < 200/mm3 or = or < 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
  • Current PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
  • Stage 2 or worse (moderate) AIDS Dementia Complex.
  • Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.

Concurrent Medication:

Excluded:

  • Acute therapy for active AIDS-defining opportunistic infection.
  • Systemic chemotherapy for malignancy.
  • Antiretroviral therapy other than that provided by this study.

Patients with the following prior conditions are excluded:

  • History of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • History of intolerance to the study drugs at entry doses and/or frequencies.
  • History of phenylketonuria.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 16 locations

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

Status Unknown

2

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 80204

Status Unknown

3

Hill Health Corp

New Haven, Connecticut, United States, 06519

Status Unknown

4

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, United States, 19899

Status Unknown

5

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States, 20422

Status Unknown

6

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

Status Unknown

7

AIDS Research Alliance - Chicago

Chicago, Illinois, United States, 60657

Status Unknown

8

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States, 70112

Status Unknown

9

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, United States, 48201

Status Unknown

10

Henry Ford Hosp

Detroit, Michigan, United States, 48202

Status Unknown

11

North Jersey Community Research Initiative

Newark, New Jersey, United States, 07103

Status Unknown

12

Addiction Research and Treatment Corp

Brooklyn, New York, United States, 11201

Status Unknown

13

Clinical Directors Network of Region II

New York, New York, United States, 10011

Status Unknown

14

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, United States, 10037

Status Unknown

15

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States, 97210

Status Unknown

16

Richmond AIDS Consortium

Richmond, Virginia, United States, 23298

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS.

L D Saravolatz, D L Winslow, G Collins...

https://pubmed.ncbi.nlm.nih.gov/8813040

Exploring causal mechanisms and quantifying direct and indirect effects using a joint modeling approach for recurrent and terminal events.

Fang Niu, Cheng Zheng, Lei Liu

https://pubmed.ncbi.nlm.nih.gov/37461207