NCT00001029 is a Phase 2 clinical trial of Zidovudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00001029?

NCT00001029 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00001029?

Interventions in NCT00001029: Zidovudine, Zalcitabine, Didanosine.

What condition does NCT00001029 study?

NCT00001029 studies HIV Infections.

Is NCT00001029 still recruiting?

NCT00001029 is currently completed. Last updated 28 October 2021.

Last reviewed 2021-10-28 · How we verify

NCT00001029

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy

Completed Phase 2 Last updated 28 October 2021

What this trial tests

Phase 2 trial testing Zidovudine in HIV Infections in 654 participants. Completed in 1 May 1993.

Timeline

1 May 1993

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	654
Estimated completion	1 May 1993
Sites	37 locations across United States, Puerto Rico, Tanzania

Drugs / interventions tested

Zidovudine (ZIDOVUDINE) — full drug profile →
Zalcitabine — full drug profile →
Didanosine (DIDANOSINE) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

13 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Zidovudine

Trials testing the same drug.

NCT03988452 — Nucleosides And Darunavir/Dolutegravir In Africa · Phase 3 · unknown
NCT02737046 — Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma · Phase 2 · completed
NCT03088410 — Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana · Phase 4 · completed
NCT02369406 — Early Infant HIV Treatment in Botswana · Phase 2, PHASE3 · active not recruiting
NCT01352715 — Study of Options for Second-Line Effective Combination Therapy (SELECT) · Phase 3 · completed

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00001029 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 28 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00001029.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing