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NCT00044577
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
Phase 3 trial testing abacavir/lamivudine in Infection, Human Immunodeficiency Virus I in 166 participants. Completed in 25 May 2004.
25 May 2004
Quick facts
| Lead sponsor | ViiV Healthcare |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 166 |
| Start date | 16 July 2002 |
| Primary completion | 25 May 2004 |
| Estimated completion | 25 May 2004 |
| Sites | 76 locations across France, Italy, Belgium, United Kingdom, Germany, Canada, Portugal, United States |
Drugs / interventions tested
- abacavir/lamivudine — full drug profile →
- abacavir (ABACAVIR) — full drug profile →
- lamivudine (LAMIVUDINE) — full drug profile →
- tenofovir — full drug profile →
Conditions studied
- Infection, Human Immunodeficiency Virus I — all drugs for Infection, Human Immunodeficiency Virus I →
- HIV Infection — all drugs for HIV Infection →
Sponsor
ViiV Healthcare — full company profile →
Who can join
18 and older, any sex, with Infection, Human Immunodeficiency Virus I or HIV Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.
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:
- PubMed search for NCT00044577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of abacavir/lamivudine
Trials testing the same drug.
- NCT00046176 — A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients · Phase 3 · completed
Other ViiV Healthcare trials
Trials by the same sponsor.
- NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
- NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not 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 NCT00044577 (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 ViiV Healthcare
- Last refreshed: 24 March 2020
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/NCT00044577.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing