Generic Combivir is used for treating HIV infection in combination with other medicines.
Other names for this medication:
Also known as: Lamivudine\Zidovudine.
Generic Combivir is an antiviral combination. Lamivudine and Zidovudine are both nucleoside analogues that work together to slow the growth of HIV by blocking an enzyme needed by the virus to reproduce.
Generic Name of Generic Combivir is Lamivudine plus Zidovudine.
Combivir is also known as Lamivudine, Zidovudine, Duovir.
Brand name of Generic Combivir is Combivir.
Generic Combivir is available in tablets which should be taken orally.
Take Generic Combivir with or without food.
Continue to use Generic Combivir even if you feel well. Do not miss any doses.
Take Generic Combivir at the same time each day.
Do not stop taking it suddenly.
If you overdose Generic Combivir and you don't feel good you should visit your doctor or health care provider immediately.
Store between 2 and 30 degrees C (36 and 86 degrees F) away from moisture and heat. Keep the container tightly closed. Throw away any unused medicine after the expiration date. Keep out of the reach of children.
The most common side effects associated with Combivir are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Be careful with Generic Combivir while you are pregnant or have nurseling. Generic Combivir can pass in breast milk and harm your baby.
Do not use Generic Combivir if you are allergic to Generic Combivir components.
Do not use Generic Combivir if you are taking stavudine, zalcitabine, or other medicines containing lamivudine or zidovudine.
Do not use Generic Combivir if you have severe kidney problems, decreased liver function, abnormal liver function tests, or high levels of lactic acid in the blood (lactic acidosis).
Be careful with Generic Combivir if you weigh less than 66 lbs (30 kg) .
Be careful with Generic Combivir if you have a history of liver problems (eg, abnormal liver function tests, hepatitis B infection) or lactic acidosis, kidney problems, a bone marrow disorder, pancreas problems, abnormal blood cell counts, or nerve or muscle problems.
Be careful with Generic Combivir if you are significantly overweight.
Be careful with Generic Combivir if you take interferon alfa or ribavirin because serious liver problems may occur; stavudine because its effectiveness may be decreased by Generic Combivir; clarithromycin, doxorubicin, rifampin, or zalcitabine because they may decrease Generic Combivir 's effectiveness; acetaminophen, ganciclovir, ibuprofen, methadone, probenecid, trimethoprim/sulfamethoxazole, valproic acid, vancomycin, or zalcitabine because they may increase the risk of Generic Combivir 's side effects or toxic effects.
Do not stop taking it suddenly.
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Of 50 participants recruited (23 to LPVr/ZDV/3TC), 48 started therapy, and 37 participants (19 on LPVr/ZDV/3TC) enrolled in the substudy. At 36 months, the LPVr/ZDV/3TC group had significantly lower limb fat [6.4 kg (0.26) versus 7.3 kg (0.31), P = 0.017] and a trend toward lower abdominal SAT compared to the LPVr/NVP group [131 cm (6.86) versus 146 cm (6.33), P = 0.097]. Over 36 months, mtDNA declined in the LPVr/ZDV/3TC group [mtDNA region 1: -190 (95) copies/cell, P = 0.053, region 2: -269 (106) copies/cell, P = 0.016] but not within the LPVr/NVP group [region 1: +28 (99) copies/cell, P = 0.78, region 2: +51 (111) copies/cell, P = 0.65, between-group difference P < 0.01 for both measurements]. mtDNA was significantly lower in the LPVr/ZDV/3TC group at 36 months.
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Acute HIV infection was verified in 16 infected subjected basing either on seroconversion (by immunoblotting) or a documented negative result 6-12 months before registration of a positive result for HIV antibodies.
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Dissolution testing has a very vital importance for a quality control test and prediction of the in vivo behavior of the oral dosage formulation. This requires the use of a powerful analytical method to get reliable, accurate and precise results for the dissolution experiments. In this context, new signal processing approaches, continuous wavelet transforms (CWTs) were improved for the simultaneous quantitative estimation and dissolution testing of lamivudine (LAM) and zidovudine (ZID) in a tablet dosage form. The CWT approaches are based on the application of the continuous wavelet functions to the absorption spectra-data vectors of LAM and ZID in the wavelet domain. After applying many wavelet functions, the families consisting of Mexican hat wavelet with the scaling factor a=256, Symlets wavelet with the scaling factor a=512 and the order of 5 and Daubechies wavelet at the scale factor a=450 and the order of 10 were found to be suitable for the quantitative determination of the mentioned drugs. These wavelet applications were named as mexh-CWT, sym5-CWT and db10-CWT methods. Calibration graphs for LAM and ZID in the working range of 2.0-50.0 µg/mL and 2.0-60.0 µg/mL were obtained measuring the mexh-CWT, sym5-CWT and db10-CWT amplitudes at the wavelength points corresponding to zero crossing points. The validity and applicability of the improved mexh-CWT, sym5-CWT and db10-CWT approaches was carried out by the analysis of the synthetic mixtures containing the analyzed drugs. Simultaneous determination of LAM and ZID in tablets was accomplished by the proposed CWT methods and their dissolution profiles were graphically explored.
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Tropical spastic paraparesis (TSP) or human T-cell leukemia virus-type 1 (HTLV-I)-associated myelopathy is caused by human T-lymphotropic virus type 1. It is a slow, progressive spastic paraparesis with significant morbidity and causing profound repercussions on quality of life. No therapies have been found to persistently improve the outcome in these patients. We present a patient with HTLV-1-associated myelopathy/TSP (HAM/TSP) who was treated with Combivir (lamivudine-zidovudine, GlaxoSmithKline, London, UK). She was walker-dependent for several years but, soon after treatment with lamivudine-zidovudine, was able to walk using only a cane. The role of lamivudine-zidovudine should be investigated further in this patient population.
To present a rare case of bilateral conjunctival molluscum contagiosum (MC) in an HIV-positive individual who had unilateral lesion excision before induction of highly active antiretroviral therapy (HAART), and to discuss the pathophysiological consequences of immune restoration.
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Several studies have reported an increased incidence of auditory dysfunction among HIV/AIDS patients. We used auditory HEI-OC1 cells in cell viability, flow cytometry and caspases 3/7-activation studies to investigate the potential ototoxicity of fourteen HIV antiretroviral agents: Abacavir, AZT, Delavirdine, Didenosine, Efavirenz, Emtricitabine, Indinavir, Lamivudine, Nefinavir, Nevirapine, Tenofovir, Ritonavir, Stavudine and Zalcitabine, as well as combinations of these agents as used in the common anti-HIV cocktails Atripla™, Combivir™, Epzicom™, Trizivir™, and Truvada™. Our results suggested that most of the single assayed anti-HIV drugs are toxic for HEI-OC1 auditory cells. The cocktails, on the other hand, decreased auditory cells' viability with high significance, with the following severity gradient: Epzicom ∼ Trizivir > Atripla ∼ Combivir > Truvada. Interestingly, our results suggest that Trizivir- and Epzicom-induced cell death would be mediated by a caspase-independent mechanism. l-Carnitine, a natural micronutrient known to protect HEI-OC1 cells against some ototoxic drugs as well as to decrease neuropathies associated with anti-HIV treatments, increased viability of cells treated with Lamivudine and Tenofovir as well as with the cocktail Atripla, but had only minor effects on cells treated with other drugs and drug combinations. Altogether, these results suggest that some frequently used anti-HIV agents could have deleterious effects on patients' hearing, and provide arguments in favor of additional studies aimed at elucidating the potential ototoxicity of current as well as future anti-HIV drugs.
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We compared biological outcomes in antiretroviral-naive patients with viral load (VL) > 5,000 copies/ml starting combivir-based, three-drug highly active antiretroviral therapy regimens in 2001-2002 according to the third component, namely abacavir (ABC), nelfinavir (NFV), indinavir/ritonavir (IDV/r), lopinavir/ritonavir (LPV/r), nevirapine (NVP) or efavirenz (EFV).
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BILR 355 is a second generation non-nucleoside reverse transcriptase inhibitor. It has shown promising in vitro anti-HIV-1 activities and favourable human pharmacokinetic properties after co-administration with ritonavir (RTV). Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor. It is excreted predominantly in urine by a transporter-mediated pathway. These two drugs are likely to be given together to HIV-infected patients. The objective of this study was to investigate any steady-state pharmacokinetic interactions between RTV-boosted BILR 355 and 3TC/zidovudine (ZDV).
In total 1309 HIV/HCV co-infected patients who had received HCV therapy were included, of whom 490 (37 %) had achieved an SVR. No statistically significant difference was seen for patients using ABC-containing regimens compared to patients using an emtricitabine + tenofovir (FTC + TDF)-containing backbone, which was the most frequently used backbone. In the multivariate analyses, patients using a protease inhibitor (PI)-boosted regimen were less likely to achieve an SVR compared to patients using a non-nucleoside reverse-transcriptase inhibitor (NNRTI)-based regimen (OR: 0.61, 95 % CI: 0.41-0.91). The backbone combinations zidovudine&lamivudine (AZT + 3TC) and stavudine&lamivudine (d4t + 3TC) were associated with lower SRV rates (0.45 (0.24-0.82) and 0.46 (0.22-0.96), respectively).
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After short-course antiretroviral prophylaxis, nevirapine was detectable in most infant cord blood samples and the concentration in maternal plasma and breast milk was high through week 1 accompanied by suppressed HIV-1 RNA in plasma and breast milk.
During the past two years, two new classes of drugs have emerged that are effective in treating HIV infection. Since protease inhibitors and non-nucleoside reverse transcriptase inhibitors are highly effective but difficult to take, pharmaceutical manufacturers have developed new formulations of some of these drugs. People taking AZT and ritonavir can sometimes switch to a product called Combivir, a combination of the two. Saquinavir patients may be able to switch to a gel formulation of the same drug, Fortovase, that is more readily absorbed by the body. Potential side effects and impacts on treatment are reviewed.
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Randomized, open-label, parallel-group, multicenter, formulation-switch study.
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Abacavir (ABC) may be associated with a small, increased risk of myocardial infarction in HIV-infected adults, possibly related to cytokine-mediated inflammation.
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Sixty-five men were randomized and treated (28 in the FTC/TDF arm and 37 in the ZDV/3TC arm), and 57 completed the study (25 and 32 in each arm, respectively). In the FTC/TDF arm, adjusted mean FMR decreased by 0.52 at week 72 (P = 0.014), and in the ZDV/3TC arm it increased by 0.13 (P = 0.491; P between arms = 0.023). Among subjects with lipoatrophy (baseline FMR ≥ 1.5), adjusted FMR decreased by 0.76 (P = 0.003) in the FTC/TDF arm and increased by 0.21 (P = 0.411; P between arms = 0.009) in the ZDV/3TC arm. Baseline FMR and treatment group were significant predictors (P < 0.05) of post-baseline changes in FMR.
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Disparities in drug exposure between formulations were observed; however, the FDC tablet delivered therapeutically adequate exposures of each drug and could well play an important role in simplifying antiretroviral treatment for children.
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Background. Study examined the determinants of mortality among adult HIV patients in a rural, tertiary hospital in southeastern Nigeria, comparing mortality among various ART regimens. Methods. Retrospective cohort study of 1069 patients on ART between August 2008 and October 2013. Baseline CD4 counts, age, gender, and ART regimen were considered in this study. Kaplan-Meier method was used to estimate survival and Cox proportional hazards models to identify multivariate predictors of mortality. Median follow-up period was 24 months (IQR 6-45). Results. 78 (7.3%) patients died with 15.6% lost to followup. Significant independent predictors of mortality include age (>45), sex (male > female), baseline CD4 stage (<200), and ART combination. Adjusted mortality hazard was 3 times higher among patients with CD4 count <200 cells/μL than those with counts >500 (95% CI 1.69-13.59). Patients on Truvada-based first-line regimens were 88% more likely to die than those on Combivir-based first line (95% CI 1.05-3.36), especially those with CD4 count <200 cells/μL. Conclusion. Study showed lower mortality than most studies in Nigeria and Africa, with mortality higher among males and patients with CD4 count <200. Further studies are recommended to further compare treatment outcomes between Combivir- and Truvada-based regimens in resource-limited settings using clinical indicators.
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A subanalysis of a controlled, randomized clinical trial in virologically suppressed HIV-1-infected men switching from zidovudine (ZDV)/lamivudine (3TC) to emtricitabine (FTC)/tenofovir (TDF) versus continuing on ZDV/3TC was carried out. FMR was assessed by dual X-ray absorptiometry (DEXA) for a period of 72 weeks. Lipoatrophy was defined as FMR ≥ 1.5. Multivariate linear regression models for the change in FMR from baseline were fitted.
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Single-dose nevirapine (sdNVP)-which prevents mother-to-child transmission of HIV-selects non-nucleoside reverse-transcriptase inhibitor (NNRTI) resistance mutations in the majority of women and HIV-infected infants receiving it. This open-label, randomised trial examined the efficacy of short-course zidovudine (AZT) and lamivudine (3TC) with sdNVP in reducing NNRTI resistance in mothers, and as a secondary objective, in infants, in a setting where sdNVP was standard-of-care.
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To evaluate the effect of antiretroviral treatment on aminotransferase serum levels in treatment-naïve patients infected with human immunodeficiency virus (HIV).
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A total of 1368 participants (76% male and 61% White, of those with available race data) were randomized and treated. No gender-related differences in response rate (percentage of patients with HIV-1 viral load < 50 HIV-1 RNA copies/mL, using an intent-to-treat, time-to-loss-of-virological-response algorithm) were observed (RPV: men, 85%; women, 83%; EFV: men, 82%; women, 83%). Response rates were lower in Black compared with Asian and White participants (RPV: 75% vs. 95% and 85%, respectively; EFV: 74% vs. 93% and 83%, respectively); this finding was mostly a result of higher discontinuation and virological failure rates in Black patients. Safety findings were generally similar across race and gender subgroups. However, nausea occurred more commonly in women than in men in both treatment groups. In men, diarrhoea was more frequent in the EFV group, and abnormal dreams/nightmares were more frequent in men in both the EFV and RPV groups.
Few data have described long-term outcomes for infants born to HIV-infected African women taking antiretroviral therapy (ART) in pregnancy. This is particularly true for World Health Organization (WHO)-recommended tenofovir-containing first-line regimens, which are increasingly used and known to cause renal and bone toxicities; concerns have been raised about potential toxicity in babies due to in utero tenofovir exposure.
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Alternatives to the available stavudine-containing paediatric fixed-dose combination (FDC) tablets are rapidly needed due to concerns regarding the cumulative toxicity of long-term stavudine exposure. We report the bioavailability and short-term safety of a novel paediatric FDC tablet of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP; 30/15/28 mg) in HIV-infected children.
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Records of 708 HIV positive hospitalised patients were reviewed, 150 patients had neurological complications; giving a six-year point prevalence of 21.2%. Males were 86 (57.3%) and females 64 (42.7%) M:F ratio = 1.3:1. Mean age was 38.84 years. The five commonest neurological complications were; cryptococcal meningitis 33 (22%), encephalitis 28 (18.7%), cerebral toxoplasmosis 19 (12.7%), stroke 19 (12.7%) and tuberculous meningitis 16 (10.7%). Overall, 72 patients (63%) had CD4+ counts done. Cryptococcal meningitis patients' CD4+ count, (mean 60, median 17, range 1-273/cmm). Encephalitis patients' CD4+count, (mean 82, median 54, range 3-495/cmm). Cerebral toxoplasmosis patients' CD4+count, (mean 59, median 58, range 11-120/cmm). Stroke patients' CD4+ count, (mean 120, median 30, range 15-394/cmm) and Tuberculous meningitis patients' CD4+ count, (mean 67, median 62 and range 12-154/cmm). The other rare neurological manifestations included peripheral neuropathy, HIV associated dementia (HAD), myelopathy and myopathy amongst others. One hundred and eight (72%) patients were on anti-retroviral therapy. The commonest drugs used in various regimen combinations included efavirenz and combivir. Fourteen (9.3%) patients died while in hospital; eight of them were among those with the top five neurological complications.
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One hundred and forty-seven patients were randomized 2:2:1 to one of two APL dosing regimens or efavirenz (EFV). All dosage arms were administered twice daily and in combination with lamivudine/zidovudine (3TC/ZDV; Combivir, COM). Efficacy, safety, and pharmacokinetic parameters were assessed.
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Overall, 219 patients treated with once-daily didanosine/lamivudine/efavirenz and 409 patients receiving twice-daily zidovudine/lamivudine (Combivir) plus efavirenz were evaluated. By intent-to treat analysis (non-completers and therapeutic change=failure), time to treatment failure was similar in both groups of treatment: 40.0 months (95% CI 23.3-56.8 months) among patients on didanosine/lamivudine/efavirenz and 33.3 months (95% CI 25.6-41.1 months) in patients treated with zidovudine/lamivudine/efavirenz (P=0.253). The risk of failure due to treatment change was almost double among patients treated with zidovudine/lamivudine/efavirenz compared with those who received didanosine/lamivudine/efavirenz.
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An international, phase 4, open-label, parallel-group, 34-centre study was conducted in 254 non-diabetic, antiretroviral-naive, HIV-infected out-patients with an HIV-1 RNA level of >1000 HIV-1 RNA copies/mL and < or =200,000 copies/mL and a CD4 cell count of >50 cells/microL.
Subjective and objective improvements in psychotic symptoms and presentation.
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Glaxo Wellcome is introducing Combivir, combining the nucleoside analogues AZT and 3TC. The new formulation was approved by the Food and Drug Administration (FDA) in September. The manufacturer hopes to improve patients' ability to take the therapy correctly by reducing the number of pills required. The combination is well tolerated, can be taken with or without food, and costs the same if the two drugs were purchased separately.
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