Last reviewed · How we verify
Combivir
At a glance
| Generic name | Combivir |
|---|---|
| Also known as | Retrovir, zidovudine, Epivir, lamivudine, GW873140 |
| Sponsor | St. Luke's-Roosevelt Hospital Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF HEPATITIS B Zidovudine, a component of COMBIVIR (lamivudine and zidovudine) tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV ‑ 1) disease [see Warnings and Precautions ( 5.1 )] . Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warn
Common side effects
- Headache
- Nausea
- Malaise & fatigue
- Nasal signs & symptoms
- Diarrhea
- Cough
- Nausea & vomiting
- Neuropathy
- Musculoskeletal pain
- Insomnia & other sleep disorders
- Fever or chills
- Dizziness
Serious adverse events
- Pancreatitis
- Lactic acidosis and hepatic steatosis
- Stevens-Johnson syndrome
- Rhabdomyolysis
- Anaphylaxis
- Cardiomyopathy
- Hepatic decompensation
- Seizures
- Erythema multiforme
- Pure red cell aplasia
Key clinical trials
- Early Infant HIV Treatment in Botswana (PHASE2, PHASE3)
- Reverse Transcriptase Inhibitors in AGS (PHASE2)
- Research on the Psychological Status of Patients With HIV-1 Infection
- A Study of Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Reduction of Mother-to-child HIV Transmission During Breastfeeding (PHASE2)
- Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma (NA)
- A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer (PHASE2)
- Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone (PHASE3)
- Effects of Maraviroc vs. Efavirenz on CD4/CD8 Ratio (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Combivir CI brief — competitive landscape report
- Combivir updates RSS · CI watch RSS
- St. Luke's-Roosevelt Hospital Center portfolio CI