NCT00001032 is a Phase 2 clinical trial of Zidovudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00001032?

NCT00001032 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00001032?

Interventions in NCT00001032: Zidovudine, Zalcitabine.

What condition does NCT00001032 study?

NCT00001032 studies HIV Infections.

Is NCT00001032 still recruiting?

NCT00001032 is currently completed. Last updated 28 October 2021.

Last reviewed 2021-10-28 · How we verify

NCT00001032

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

A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

Completed Phase 2 Last updated 28 October 2021

What this trial tests

Phase 2 trial testing Zidovudine in HIV Infections in 180 participants. Completed in 1 April 1995.

Timeline

1 April 1995

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	180
Estimated completion	1 April 1995
Sites	47 locations across United States, Puerto Rico

Drugs / interventions tested

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

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 3 Months to 12, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

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 NCT00001032 (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/NCT00001032.

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