NCT00000640 is a Phase 3 clinical trial of Primaquine in Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00000640?

NCT00000640 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00000640?

Interventions in NCT00000640: Primaquine, Sulfamethoxazole-Trimethoprim, Dapsone, Clindamycin.

What condition does NCT00000640 study?

NCT00000640 studies Pneumonia, Pneumocystis Carinii, HIV Infections.

Is NCT00000640 still recruiting?

NCT00000640 is currently completed. Last updated 26 October 2021.

Last reviewed 2021-10-26 · How we verify

NCT00000640

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

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Trimethoprim / Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

Completed Phase 3 Last updated 26 October 2021

What this trial tests

Phase 3 trial testing Primaquine in Pneumonia, Pneumocystis Carinii in 290 participants. Completed in 1 September 1994.

Timeline

1 September 1994

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Masking	double
Primary purpose	treatment
Enrollment	290
Estimated completion	1 September 1994
Sites	32 locations across United States

Drugs / interventions tested

Primaquine — full drug profile →
Sulfamethoxazole-Trimethoprim — full drug profile →
Dapsone (DAPSONE) — full drug profile →
Clindamycin (clindamycin) — full drug profile →

Conditions studied

Pneumonia, Pneumocystis Carinii — all drugs for Pneumonia, Pneumocystis Carinii →
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 Pneumonia, Pneumocystis Carinii or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.

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 Primaquine

Trials testing the same drug.

NCT06666491 — An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken · Phase 3 · recruiting
NCT06191458 — Postpartum Primaquine in Breast Milk · Phase 4 · completed
NCT06148792 — A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria · Phase 3 · recruiting
NCT06294912 — A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) · Phase 1 · completed
NCT04984759 — Tafenoquine and Primaquine in Colostrum and Breast Milk · Phase 4 · withdrawn

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 NCT00000640 (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: 26 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/NCT00000640.

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