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NCT00106171
A Randomized Trial of HAART in Acute/Early HIV Infection
Phase 4 trial testing Highly active antiretroviral therapy (HAART) in HIV Infections in 113 participants. Completed in 1 May 2012.
1 May 2012
Quick facts
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 113 |
| Start date | 1 May 2005 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 5 locations across United States, Canada |
Drugs / interventions tested
- Highly active antiretroviral therapy (HAART) — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
Johns Hopkins Bloomberg School of Public Health
Who can join
18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Total Treatment-free Time to Initiation of Permanent HAART
Time frame: Through study completion, an average of 18 months
All HAART-free time from initial infection with HIV to initiation of permanent HAART
Sponsor's own description
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
HIV-1 Gag evolution in recently infected human leukocyte antigen-B*57 patients with low-level viremia.
Durand CM, O'Connell KA, Apuzzo LG, Langan SJ, et al · · 2010 · cited 10× · PMID 20671542 · DOI 10.1097/qad.0b013e32833d8a38 -
HIV-1 evolution following transmission to an HLA-B*5801-positive patient.
O'Connell KA, Xu J, Durbin AP, Apuzzo LG, et al · · 2009 · cited 10× · PMID 19909081 · DOI 10.1086/648377 -
A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection.
Margolick JB, Apuzzo L, Singer J, Wong H, et al · · 2015 · cited 1× · PMID 26600459 · DOI 10.1371/journal.pone.0143259
Verify or expand the search:
- PubMed search for NCT00106171
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Highly active antiretroviral therapy (HAART)
Trials testing the same drug.
- NCT00955968 — IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women · Phase 4 · 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 Johns Hopkins Bloomberg School of Public Health trials
Trials by the same sponsor.
- NCT07458230 — Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation: · Phase 3 · not yet recruiting
- NCT07227558 — Improving Information Sharing Between Family Caregivers and Home Care Aides · NA · recruiting
- NCT07536126 — Testing Non-Nutrition Menu Labels on Food Selections · NA · not yet recruiting
- NCT06426004 — Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland · NA · not yet recruiting
- NCT07344142 — Improving Digital Wellbeing in Saudi Adolescents · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00106171 (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 Johns Hopkins Bloomberg School of Public Health
- Last refreshed: 22 August 2023
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/NCT00106171.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing