NCT01066858 is a clinical trial of Tenofovir disoproxil fumarate (TDF) in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT01066858?

NCT01066858 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT01066858?

Interventions in NCT01066858: Tenofovir disoproxil fumarate (TDF).

What condition does NCT01066858 study?

NCT01066858 studies HIV Infections.

Is NCT01066858 still recruiting?

NCT01066858 is currently completed. Last updated 23 September 2022.

Last reviewed 2022-09-23 · How we verify

NCT01066858

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

Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

Completed Last updated 23 September 2022

What this trial tests

trial testing Tenofovir disoproxil fumarate (TDF) in HIV Infections in 1,765 participants. Completed in 30 November 2015.

Timeline

22 March 2011

Primary endpoint
30 November 2015

30 November 2015

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,765
Start date	22 March 2011
Primary completion	30 November 2015
Estimated completion	30 November 2015
Sites	11 locations across Zimbabwe, South Africa, Malawi, Uganda

Drugs / interventions tested

Tenofovir disoproxil fumarate (TDF) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

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

Sponsor's own description

The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial.
Stranix-Chibanda L, Tierney C, Sebikari D, Aizire J, et al · · 2021 · cited 12× · PMID 33544759 · DOI 10.1371/journal.pone.0246272
Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial.
Baltrusaitis K, Makanani B, Tierney C, Fowler MG, et al · · 2022 · cited 5× · PMID 35858874 · DOI 10.1186/s12879-022-07608-8
Bone mineral density changes in breastfeeding women with HIV on antiretroviral therapy in Eastern and Southern Africa.
Matovu Kiweewa F, Stranix-Chibanda L, Yende-Zuma N, Dadabhai S, et al · · 2025 · cited 1× · PMID 39918445 · DOI 10.1097/qad.0000000000004148
Brief Report: Postpartum Maternal Monitoring for Renal Safety Related to Tenofovir Exposure During Breastfeeding in the PROMISE 1077BF Randomized Trial.
Baltrusaitis K, Tierney C, Fowler MG, Owor M, et al · · 2026 · PMID 41474755 · DOI 10.1097/qai.0000000000003829

Verify or expand the search:

Other trials of Tenofovir disoproxil fumarate (TDF)

Trials testing the same drug.

NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed
NCT02258581 — Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B · terminated

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 NCT01066858 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 23 September 2022

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/NCT01066858.

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