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NCT00158405
Multicentric Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy (HAART) Compared With a Continuous HAART in HIV- Infected Adults in Abidjan
Phase 3 trial testing Structured Treatment Interruption in HIV Infections in 840 participants. Completed in 1 December 2006.
Quick facts
| Lead sponsor | French National Agency for Research on AIDS and Viral Hepatitis |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 840 |
| Start date | 1 December 2002 |
| Estimated completion | 1 December 2006 |
| Sites | 5 locations across Côte d’Ivoire |
Drugs / interventions tested
- Structured Treatment Interruption — full drug profile →
- Zidovudine (ZDV) — full drug profile →
- Lamivudine (3TC)
- Efavirenz (EFV) — full drug profile →
- Ritonavir (NRV) — full drug profile →
- Indinavir (IDV) — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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.
- To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :
- Percentage of patients with CD4 count over 350 per mm3
- Incidence of severe morbidity
- Incidence of mortality
Sponsor's own description
Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial.
Danel C, Moh R, Minga A, Anzian A, et al · · 2006 · cited 159× · PMID 16782488 · DOI 10.1016/s0140-6736(06)68887-9 -
Clinical Outcomes during Treatment Interruptions in Human Immunodeficiency Virus-Hepatitis B Virus Co-infected Patients from Sub-Saharan Africa.
Boyd A, Houghtaling L, Moh R, Chekaraou MA, et al · · 2017 · cited 6× · PMID 29141712 · DOI 10.4269/ajtmh.16-1016
Verify or expand the search:
- PubMed search for NCT00158405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Structured Treatment Interruption
Trials testing the same drug.
- NCT00021762 — Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV · Phase 2 · withdrawn
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
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Other French National Agency for Research on AIDS and Viral Hepatitis trials
Trials by the same sponsor.
- NCT03671291 — Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV · NA · completed
- NCT04468724 — MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area · NA · unknown
- NCT03459768 — Cohort Study on People Who Inject Drugs in Senegal · unknown
- NCT00927290 — Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance · Phase 3 · terminated
- NCT00823342 — ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus · Phase 3 · terminated
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 NCT00158405 (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 French National Agency for Research on AIDS and Viral Hepatitis
- Last refreshed: 29 December 2008
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/NCT00158405.
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